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

Bayer108 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

Contraception Ovulation Inhibition

Interventions

Ethinylestradiol/Gestodene (BAY86-5016)DRUG

Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)

Ethinylestradiol/Gestodene (BAY86-5016)DRUG

Transdermal patch: 0.55mg Ethinylestradiol (EE+1.05mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Berlin, State of Berlin, Germany

Unnamed facility

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3

Time frame: 4 months

Secondary Outcomes

The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3

Time frame: 4 months

Course of gonadotropins (FSH, LH, P, E2)

Time frame: 4 months

Endometrial thickness and Follicle size

Time frame: 4 months

Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3

Time frame: 4 Months

Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3

Time frame: 4 Months

Data from ClinicalTrials.gov

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