Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation During Treatment With Three Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol (EE) and 2.10 mg Gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles
Overview
- Phase
- Phase 2
- Intervention
- Gestodene/EE Patch (BAY86-5016)
- Conditions
- Contraception
- Sponsor
- Bayer
- Enrollment
- 173
- Primary Endpoint
- Hoogland score to evaluate the inhibition of ovulation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals.
With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy female volunteers
- •age 18 - 35 years (smoker not older than 30 years, inclusive)
- •ovulatory pre-treatment cycle
Exclusion Criteria
- •Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
- •Regular intake of medication other than Oral Contraception
- •Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
Arms & Interventions
Arm 1
Intervention: Gestodene/EE Patch (BAY86-5016)
Arm 2
Intervention: Gestodene/EE Patch (BAY86-5016)
Arm 3
Intervention: Gestodene/EE Patch (BAY86-5016)
Outcomes
Primary Outcomes
Hoogland score to evaluate the inhibition of ovulation
Time Frame: After 2 months
Secondary Outcomes
- Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone(After 2 months)
- Follicle size measured by transvaginal ultrasound examination(After 2 months)
- Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)(After 2 months)