Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).

A 60-month Non-comparative Study on Bleeding Profiles With Levonorgestrel Intrauterine System in Transition From Reproductive Age Contraception to Menopause Age Endometrial Protection During Estrogen Replacement Therapy.

The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Drug: LNG IUS

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

• Study Type: Interventional
• Enrollment (Actual): 394
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
  • HUY, Belgium, 4500
• Finland
  • Espoo, Finland, 02100
  • Turku, Finland, 20520
  • Turku, Finland, 20100
• Netherlands
  • Heerlen, Netherlands, 6419 PC
  • Venlo, Netherlands, 5912 BL
  • Zaandam, Netherlands, 1502 DV
  • Zwijndrecht, Netherlands, 3331 LZ
• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE4 6BE
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB23 2TN
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2JB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 51 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.

Exclusion Criteria:

• Pregnancy or lactation.
• Previous pelvic infections.
• Abnormal bleeding.
• Abnormal uterine cavity.
• Uterine polyps.
• Genital cancer.
• Liver diseases.
• Alcoholism or drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: LNG IUS; Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.

Drug: LNG IUS; LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Bleeding Days	Measured by using Subject Diaries (Subject Reported Data)	Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase
Number of Spotting Days	Measured by using Subject Diaries (Subject Reported Data)	Last 90 days in Contraception Phase and first 360 days in HRT Phase
Percentage of Participants With Successful Treatment	Definition of successful treatment: Completion of HRT phase, and; Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and; The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT	Last 90 days in Contraception Phase and first 360 days in HRT Phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of QOL as Measured by Women's Health Questionnaire	Women's Health Questionnaire (Total Score). For the Total score, the minimum is 36 and maximum is 144. A higher score means the distress and dysfunction are less pronounced.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Continuation Rates	Percentage of subjects continuing in the study at the given time points.	At entry, at 2 years, at 4 years
Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 4: Nausea (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 5: Edema (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 5: Irritability (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 6: Breast Tension (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Depypere HT, Hillard T, Erkkola R, Lukkari-Lax E, Kunz M, Rautiainen P, Schram JH. A 60-month non-comparative study on bleeding profiles with the levonorgestrel intrauterine system from the late transition period to estrogen supplemented menopause. Eur J Obstet Gynecol Reprod Biol. 2010 Dec;153(2):176-80. doi: 10.1016/j.ejogrb.2010.08.017.

Study record dates

Study Major Dates

• Study Start: May 1, 2000
• Primary Completion (ACTUAL): May 1, 2008
• Study Completion (ACTUAL): May 1, 2008

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (ESTIMATE): September 16, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 90660; 300400 (OTHER: Company Internal)