Effects of SH T00658ID on Libido

Multi-center, Double-blind, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive Containing Estradiol Valerate and Dienogest (SH T00658ID) Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon) Over 6 Treatment Cycles on Alleviating Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With Oral Contraceptive Use

The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.

Study Overview

• Status: Completed
• Conditions: Contraception; Libido
• Intervention / Treatment: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID); Drug: Microgynon; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Ashfield, New South Wales, Australia, 2031
      • Sydney Centre for Reproductive Health Reseach
    • Sydney, New South Wales, Australia, 2031
      • Royal Hospital for Women
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Prahran, Victoria, Australia, 3121
      • The Alfred Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Queen Elizabeth II Medical Centre
    • Subiaco, Western Australia, Australia, 6008
      • King Edward Memorial Hospital
• Austria
  • Wien, Austria, 1070
    • Dr. Brigitte Wiesenthal
  • Wien, Austria, 1200
    • Dr. Wolfgang Bartl
  • Wien, Austria, 1090
    • Clin Pharm International GmbH Studienzentrum Wien
  • Zeltweg, Austria, 8740
    • Dr. Walter Paulik
  • Niederösterreich
    • St. Pölten, Niederösterreich, Austria, 3100
      • Ordination Dr. Schmidl-Amann
  • Steiermark
    • Graz, Steiermark, Austria, 8010
      • Ordination Dr.Hohlweg
    • Graz, Steiermark, Austria, 8044
      • Ordination Dr. Schaffer
• Belgium
  • Bruxelles - Brussel, Belgium, 1070
    • Hôpital Erasme/Erasmus Ziekenhuis
  • Gent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
• Germany
  • Hamburg, Germany, 20357
    • Praxis Dr. A. Schwenkhagen-Stodieck
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • Universitätsklinikum Freiburg
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Universitätsklinikum Aachen
  • Sachsen
    • Leipzig, Sachsen, Germany, 04207
      • Frauenarztpraxis Dr. Bernd Pittner
• Italy
  • Catania, Italy, 95123
    • A.O.U. Policlinico - Vittorio Emanuele
  • Pavia, Italy, 27100
    • IRCCS Fondazione Maugeri - Montescano (Pavia)
  • Pisa, Italy, 56126
    • A.O.U. Pisana
  • Cagliari
    • Monserrato, Cagliari, Italy, 09124
      • A.O.U. di Cagliari
• Spain
  • Alicante, Spain, 03013
    • Centro de Planificacion Familiar Alicante 3
  • Barcelona, Spain, 08028
    • USP Institut Universitari Dexeus
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Madrid, Spain, 28009
    • Instituto Palacios de Salud y Medicina de la Mujer
  • Barcelona
    • Gava, Barcelona, Spain, 08850
      • Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Mahidol
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodhi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon
• Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline

Exclusion Criteria:

• Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID); Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID); Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose
Active Comparator: EE/LNG (Microgynon) + Placebo; Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.	Drug: Microgynon; Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles.; Drug: Placebo; Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)	Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).	Baseline up to Cycle 6 (28 days per Cycle)
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)	Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).	Baseline up to Cycle 6 (28 days per Cycle)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline	Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).	At Baseline
The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6	Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)	Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline	Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).	At Baseline
The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6	Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)	Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline	Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).	At Baseline
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6	Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)	Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline	Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).	At Baseline
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6	Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)	Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline	Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).	At Baseline
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6	Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)	Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.	Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).	At Baseline
The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6	Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)	Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Total Score at Baseline	The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).	At Baseline
The Mean Absolute Values of FSFI Total Score at Cycle 6	The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Total Score	The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline	Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).	At Baseline
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6	Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score	Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline	Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).	At Baseline
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6	Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline	The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant	At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6	The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score	Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline	Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6	Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety	Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline	Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6	Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood	Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline	Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6	Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being	Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline	Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6	Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control	Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline	General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6	General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health	General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline	Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6	Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality	Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6	CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.	At Cycle 6 (28 days per Cycle)
Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6	In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.	At Cycle 6 (28 days per Cycle)
Vaginal Effects Evaluated by Vaginal pH at Cycle 6	Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick	At Cycle 6 (28 days per Cycle)
Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline	ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).	At Baseline
Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6	ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).	At Cycle 6 (28 days per Cycle)
Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)	ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).	Baseline up to Cycle 6 (28 days per Cycle)
Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline	The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).	At Baseline
Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6	The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).	At Cycle 6 (28 days per Cycle)
Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)	The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).	Baseline up to Cycle 6 (28 days per Cycle)
Number of Bleeding / Spotting Days in Reference Period 1	Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90
Number of Bleeding / Spotting Days in Reference Period 2	Reference Period 2 is defined as Day 91 to 180 during study treatment	From Day 91 to Day 180
Number of Bleeding / Spotting Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes	From Day 1 to Day 90
Number of Bleeding / Spotting Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment	From Day 91 to Day 180
Mean Length of Bleeding / Spotting Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes	From Day 1 to Day 90
Mean Length of Bleeding / Spotting Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180
Maximum Length of Bleeding / Spotting Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90
Maximum Length of Bleeding / Spotting Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180
Number of Spotting Only Days in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90
Number of Spotting Only Days in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180
Number of Spotting Only Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90
Number of Spotting Only Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180
Mean Length of Spotting-only Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90
Mean Length of Spotting-only Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180
Maximum Length of Spotting-only Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90
Maximum Length of Spotting-only Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 1 (28 days per Cycle)
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 3 (28 days per Cycle)
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 6 (28 days per Cycle)
Length of Withdrawal Bleeding Episodes at Cycle 1	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 1 (28 days per Cycle)
Length of Withdrawal Bleeding Episodes at Cycle 3	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 3 (28 days per Cycle)
Length of Withdrawal Bleeding Episodes at Cycle 6	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 6 (28 days per Cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.	At Cycle 1 (28 days per Cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.	At Cycle 3 (28 days per Cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.	At Cycle 6 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.	At Cycle 1 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.	At Cycle 3 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.	At Cycle 6 (28 days per Cycle)
Onset of Withdrawal Bleeding Episodes at Cycle 1	Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1
Onset of Withdrawal Bleeding Episodes at Cycle 3	Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3
Onset of Withdrawal Bleeding Episodes at Cycle 6	Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 1 (28 days per Cycle)
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 3 (28 days per Cycle)
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 6 (28 days per Cycle)
Number of Intracyclic Bleeding Episodes at Cycle 1	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 1 (28 days per Cycle)
Number of Intracyclic Bleeding Episodes at Cycle 3	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 3 (28 days per Cycle)
Number of Intracyclic Bleeding Episodes at Cycle 6	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 6 (28 days per Cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 1 (28 days per Cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 3 (28 days per Cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 6	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 6 (28 days per Cycle)
Number of Intracyclic Bleeding Days at Cycle 1	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 1 (28 days per Cycle)
Number of Intracyclic Bleeding Days at Cycle 3	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 3 (28 days per Cycle)
Number of Intracyclic Bleeding Days at Cycle 6	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 6 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.	At Cycle 1 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.	At Cycle 3 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.	At Cycle 6 (28 days per Cycle)
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	Up to Cycle 6 (28 days per Cycle)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Davis SR, Bitzer J, Giraldi A, Palacios S, Parke S, Serrani M, Mellinger U, Nappi RE. Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. J Sex Med. 2013 Dec;10(12):3069-79. doi: 10.1111/jsm.12310. Epub 2013 Sep 12.

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Oral contraceptive; Sexual dysfunction; Libido
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Contraceptives, Postcoital, Hormonal; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
• Other Study ID Numbers: 91548; 2008-002263-13 (EudraCT Number); 310785 (Other Identifier: Company Internal)