Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

Bayer

Status and phase: Completed; Phase 2

Conditions: Contraception; Ovulation Inhibition

Treatments: Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00915915

2009-009177-10 (EudraCT Number)

14348

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

Enrollment: 108 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI: 18 BMI 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/artial thromboembolic disease
• Regular intake of medication other than OCs
• Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Arm 2

Experimental group

Treatment:

Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Drug: Ethinylestradiol/Gestodene (BAY86-5016)