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:

NCT01204190

EudraCT Number:

2010-021255-81

Study Completed

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
173
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Dinox GmbH Berlin

Berlin, Germany, 10115

Status
Completed
 
Locations

Dinox B.V.

Groningen, Netherlands, 9713 GZ

Status
Completed
 

Trial Design