- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00778609
Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache
January 13, 2016 updated by: Bayer
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Microgynon on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment
The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
449
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Ashfield, New South Wales, Australia, 2031
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Blacktown, New South Wales, Australia, 2148
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Caringbah, New South Wales, Australia, 2229
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Sydney, New South Wales, Australia, 2031
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Queensland
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Fortitude Valley, Queensland, Australia, 4006
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Kipparing, Queensland, Australia, 4021
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South Australia
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Adelaide, South Australia, Australia, 5005
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Norwood, South Australia, Australia, 5065
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Victoria
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Clayton, Victoria, Australia, 3163
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Western Australia
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Nedlands, Western Australia, Australia, 6009
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Subiaco, Western Australia, Australia, 6008
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Helsinki, Finland, 00260
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Helsinki, Finland, 00100
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Helsinki, Finland, 00350
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Kuopio, Finland, 70100
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Kuopio, Finland, 70110
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Brignoles, France, 83170
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Maison Lafitte, France, 78600
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Nancy, France, 54042
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Nantes, France, 44093
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Nantes, France, 44000
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Olivet, France, 45160
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Paris, France, 75018
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Paris, France, 75015
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Paris, France, 75007
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Saint Germain En Laye, France, 78100
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Seclin, France, 59113
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Tarare, France, 69170
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Toulouse, France, 31000
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Hamburg, Germany, 22359
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Baden-Württemberg
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Rheinstetten, Baden-Württemberg, Germany, 76287
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Hessen
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Frankfurt, Hessen, Germany, 60322
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Niedersachsen
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Hannover, Niedersachsen, Germany, 30459
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Nordrhein-Westfalen
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Bochum, Nordrhein-Westfalen, Germany, 44787
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Essen, Nordrhein-Westfalen, Germany, 45127
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Wuppertal, Nordrhein-Westfalen, Germany, 42103
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Sachsen
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Dresden, Sachsen, Germany, 01067
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Leipzig, Sachsen, Germany, 04103
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Germany, 39126
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23538
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Mexico, D.F., Mexico, 3100
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México, D.F., Mexico, 07760
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México
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Mexico, México, Mexico, 06700
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Sonora
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Hermosillo, Sonora, Mexico, 83100
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Barcelona, Spain, 08013
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Madrid, Spain, 28001
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Alicante
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Benidorm, Alicante, Spain, 03503
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Petrer, Alicante, Spain, 03610
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Asturias
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Gijón, Asturias, Spain, 33212
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Catalunya
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Barcelona, Catalunya, Spain, 08003
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Bern, Switzerland, 3010
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Bern, Switzerland, 3013
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Zürich, Switzerland, 8091
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Basel-Stadt
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Basel, Basel-Stadt, Switzerland, 4031
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10700
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Bangkok, Thailand, 10330
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London, United Kingdom, W12 0NN
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Cheshire
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Cheadle, Cheshire, United Kingdom, SK8 5LL
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Middlesex
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Northwood, Middlesex, United Kingdom, HA6 2RN
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North Somerset
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Weston-super-Mare, North Somerset, United Kingdom, BS23 4BP
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG2 4PJ
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Stratchclyde
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Glasgow, Stratchclyde, United Kingdom, G45 9AW
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age between 18 and 50 years (inclusive) at visit 1, for smokers up to 35 years (inclusive)
- Otherwise healthy female subjects requesting contraception and currently using a levonorgestrel, gestodene or desogestrel containing oral contraceptive in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average value of >/= 35 mm for the 3 highest values on a visual analogue scale during cycle days 22-28.
- Normal or clinically insignificant cervical smear not requiring further follow up (or a normal result obtained within the last 6 months before screening)
- Able to tolerate ibuprofen and willing to use only ibuprofen supplied for the study.
Exclusion Criteria:
- Women with any contraindication for oral contraceptive use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Arm 2
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Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG).
Day 22 to 28 placebo
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Experimental: Arm 1
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Estradiol valerate (EV) and dienogest (DNG).
Sequential 4-phasic regimen.
Daily oral administration of one capsule SH T00658ID for 28 days per cycle for 6 treatment cycles no pill-free interval
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To compare SH T00658ID (Qlaira) to Microgynon with regard to changes in frequency and intensity of the hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28 combined into a single endpoint
Time Frame: Baseline to cycle 6
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Baseline to cycle 6
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Rescue medication consumption
Time Frame: Baseline to cycle 6
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Baseline to cycle 6
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Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28
Time Frame: Baseline to cycle 6
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Baseline to cycle 6
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Prevalence of individual hormone-related symptoms during cycle days 1 to 21
Time Frame: Baseline to cycle 6
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Baseline to cycle 6
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Prevalence of individual hormone-related symptoms during hormone-free interval, i.e. cycle days 27+28 for EV/DNG capsules and cycle days 22 to 28 for the comparator
Time Frame: Baseline, cycle 3 and cycle 6
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Baseline, cycle 3 and cycle 6
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Change in the average of the 3 highest VAS values of the hormone withdrawal associated symptoms pelvic pain or headache during cycle days 22 to 28 from baseline to cycle 3
Time Frame: Baseline to cycle 3
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Baseline to cycle 3
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Bleeding pattern and cycle control
Time Frame: Throughout
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Throughout
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QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)
Time Frame: Baseline, cycle 2 and cycle 5
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Baseline, cycle 2 and cycle 5
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AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight
Time Frame: Throughout
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Throughout
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General physical and gynecological examination
Time Frame: Screening and Final Visit
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Screening and Final Visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
October 22, 2008
First Submitted That Met QC Criteria
October 22, 2008
First Posted (Estimate)
October 23, 2008
Study Record Updates
Last Update Posted (Estimate)
January 14, 2016
Last Update Submitted That Met QC Criteria
January 13, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Headache
- Pelvic Pain
- 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
- 91550
- 310787 (Other Identifier: Company Internal)
- 2008-003226-42 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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