Multicenter, open-label, randomized study to evaluate inhibition of ovulation of two transdermal patch formulations containing 0.55 mg ethinylestradiol and either 1.05 or 2.1 mg gestodene in healthy young female volunteers over a period of 3 treatment cycles - Inhibition of ovulation and pharmacokinetics of transdermal EE and GSD
- Conditions
- The trial will be performed in healthy female volunteers. The intended indication is femal contraception.
- Registration Number
- EUCTR2009-009177-10-DE
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Signed informed consent prior to study participation and confirmation of the volunteer’s health insurance coverage
Healthy female volunteer
Age: 18 – 35 years (inclusive) at the first screening examination (smokers not older than 30 years, inclusive)
Body mass index (BMI): 18 = BMI < = 30 kg/m²
At least 3 months since delivery, abortion, or lactation before the screening visit
Willingness to use non-hormonal methods of contraception during the entire study
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
Contraindications for use of a combined (estrogen/progesteron) contraception (e.g. history of venous/arterial thromembolic disease)
regular intake of medication other than OCs
Clinical relevant findings (heart rate, blood pressure, physical, gynecological examination, laboratory examination)
Anovulatory pre-treatment cycle
Skin diseases with suspected alteration of dermal resorption and/or increased risk for dermal intolerance (e.g. psoriasis, neurodermitis, urticaria)
Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the inhibition of ovulation in treatment cycles 2 and 3 administration of two different patches containing ethinylestradiol (EE) / gestodene (GSD) for 3 treatment cycles;Secondary Objective: The following evaluations represent the secondary objectives:<br>Ovarian activity during treatment cycles 2 and 3 (Hoogland score)<br>Course of gonadotropins (FSH, LH), progesterone and E2<br>Endometrial thickness<br>Follicle size<br>Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3<br>Pharamcokinetics of EE, GSD and SHBG in treatment cycles 2 and 3<br>Proof of ovulation in the follow-up cycle;Primary end point(s): The primary variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.g. Hoogland score 6) with the levels yes and no
- Secondary Outcome Measures
Name Time Method