Trial Condition(s):
Inhibition of ovulation, patch, ethinylestradiol and gestodene
91558
Not Available
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
- 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
- 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
Locations | |
---|---|
Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Schering Pharma AG - Clin. Pharm. Berlin Berlin, Germany, 13342 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Landesamt für Gesundheit und Soziales Berlin, Germany, 10707 | Contact Us: E-mail: [email protected] Phone: Not Available |
Multicenter, open-label, randomized, uncontrolled study to evaluate inhibition of ovulation of two transdermal patch formulations containing 0.55 mg EE and either 1.05 or 2.1 mg GSD in healthy young female vol. over a period of 3 treatment cycles
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2