A multi-centre, randomized, double-blind, active control, parallel-group, 2-arm study to investigate the effect of ethinylestradiol / drospirenone / (0.02 mg/3 mg) oral contraception in a 24/4 regimen compared to ethinylestradiol / desogestrel (0.02 mg/0.15 mg) oral contraception in a 21/7 regimen on hormone withdrawal associated symptoms in otherwise healthy women after 4 cycles of treatment. - Comparative trial in hormone withdrawal associated symptoms
- Conditions
- Oral contraceptionMedDRA version: 9.1Level: PTClassification code 10030970
- Registration Number
- EUCTR2009-014911-11-IT
- Lead Sponsor
- Bayer Healthcare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 680
Subjects on a low-dose oral contraceptive in a 21-day regimen suffering from hormone withdrawal associated symptoms such as headache, pelvic pain or bloating and requiring further OC use.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Known or suspected pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or lactation before start of treatment).
2. Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.
3. Presence or history of prodromi of a thrombosis (e.g. transient ischemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. Hereditary or acquired predisposition for venous or arterial thrombosis, such as APC-resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To show superiority of 24/4 OC (EE 0.02 mg / DRSP 3 mg ) over 21/7 OC (EE 0.02 mg / DSG 0.15 mg ) on hormone withdrawal associated symptoms after 4 cycles of treatment.;Secondary Objective: To compare 24/4 OC to 21/7 OC (with regard to change from baseline to cycle 4 in the sum of individual scores during cycle days 22 28 (AUC of days 22 - 28 for each score) change from baseline to cycle 4 in number of days, where individual hormone-withdrawal symptoms are present on cycle days 22 28 (i.e. Likert Scale >= 1).;Primary end point(s): The primary efficacy variable is the change from baseline to cycle 4 in the sum of composite score during cycle days 22 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales).
- Secondary Outcome Measures
Name Time Method