Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene

Bayer

Status and phase

Terminated

Phase 2

Conditions

Contraception

Ovulation Inhibition

Treatments

Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00729404

2008-001198-13 (EudraCT Number)

91558

Details and patient eligibility

About

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

Full description

Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.

Enrollment

17 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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