Trial Condition(s):
Ovulation inhibition
Ovulation inhibition of two 4-phasic oral contraceptive regimens
Bayer Identifier:
91271
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.
Inclusion Criteria
- Healthy women willing to use non-hormonal methods of contraception
Exclusion Criteria
- Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease
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, comparative study to evaluate ovulation inhibition with two 4-phasic oral contraceptive regimens containing estradiol valerate and dienogest applied daily for three cycles to 200 healthy female volunteer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)Timeframe: Treatment cycles 2 and 3
Secondary Outcome
- Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)Timeframe: Treatment cycles 2 or 3
- Measurements of endometrial thicknessTimeframe: Treatment cycles 2 and 3
- Visibility of cervical mucusTimeframe: Treatment cycles 2 and 3
- Ovarian activity (Hoogland score)Timeframe: Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3
- Measurements of follicle sizeTimeframe: Treatment cycles 2 and 3
- Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)Timeframe: Treatment cycles 2 and 3
- ComplianceTimeframe: Throughout whole study
- Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signsTimeframe: Various timepoint throughout the study
Additional Information
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