Trial Condition(s):
Contraception
Investigation of three contraceptive hormone patches in regard to inhibition of ovulation following application over 3 treatment cycles in healthy, young women.
Bayer Identifier:
15264
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dinox B.V. Groningen, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Hoogland score to evaluate the inhibition of ovulationTimeframe: After 2 months
Secondary Outcome
- Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesteroneTimeframe: After 2 months
- Follicle size measured by transvaginal ultrasound examinationTimeframe: After 2 months
- Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)Timeframe: After 2 months
Additional Information
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