Status:
TERMINATED
Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene
Lead Sponsor:
Bayer
Conditions:
Contraception
Ovulation Inhibition
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers
Detailed Description
Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.
Eligibility Criteria
Inclusion
- Signed informed consent,
- BMI: 18 - 30 kg/m²,
- Healthy female volunteers,
- Age 18-35 years (smoker not older than 30 years, inclusive),
- Ovulatory pre-treatment cycle, at least 3 month since delivery,
- Abortion or lactation before the first screening examination,
- Willingness to use non-hormonal methods of contraception during entire study
Exclusion
- Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/arterial thromboembolic disease
- Regular intake of medication other than OCs
- Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination)
- Anovulatory pre-treatment cycle
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00729404
Start Date
August 1 2008
End Date
February 1 2009
Last Update
December 2 2014
Active Locations (3)
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1
Berlin, State of Berlin, Germany, 10115
2
Berlin, State of Berlin, Germany, 10707
3
Berlin, State of Berlin, Germany, 13342