A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles

Bayer103 enrolled

Overview

Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

103

Conditions

Contraception

Interventions

BAY86-4891 (Estradiol / Drospirenone)DRUG

Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles

BAY86-4891 (Estradiol / Drospirenone)DRUG

Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy female volunteers, * Age 18 - 35 years Exclusion Criteria: * Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease) * Regular intake of medication * Clinically relevant findings (ECG, blood pressure, physical, gynecological 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, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no

Time frame: 12 months

Secondary Outcomes

Assessment of ovarian activity in treatment cycles 2 and 3

Time frame: 12 months

Course of gonadotropins (FSH, LH)

Time frame: 12 months

Endometrial growth

Time frame: 12 months

Pharmacokinetics of estrogen and progestin in treatment cycle 3

Time frame: 12 months

Data from ClinicalTrials.gov

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