Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.

Phase 2CompletedNCT01204190

Bayer173 enrolled

Overview

The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals. With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

173

Conditions

Contraception

Interventions

0.55 mg ethinyl estradiol (EE) + 2.1 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days

Gestodene/EE Patch (BAY86-5016)DRUG

0.35 mg ethinyl estradiol (EE) + 0.67 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days

Gestodene/EE Patch (BAY86-5016)DRUG

0.275 mg ethiny estradiol (EE) + 1.05 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy female volunteers * age 18 - 35 years (smoker not older than 30 years, inclusive) * ovulatory pre-treatment cycle Exclusion Criteria: * Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease) * Regular intake of medication other than Oral Contraception * Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)

Locations (2)

Unnamed facility

Berlin, State of Berlin, Germany

Unnamed facility

Groningen, Netherlands

Outcomes

Primary Outcomes

Hoogland score to evaluate the inhibition of ovulation

Time frame: After 2 months

Secondary Outcomes

Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone

Time frame: After 2 months

Follicle size measured by transvaginal ultrasound examination

Time frame: After 2 months

Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)

Time frame: After 2 months

Data from ClinicalTrials.gov

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