Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D

Bayer105 enrolled

Overview

In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on "contraceptive robustness" of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

105

Conditions

Contraceptives, Oral

Interventions

YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)DRUG

SH T 00186 D in a 24-day regimen, i.e., 24 verum tablets, 4 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each

Yasminelle (SH T 00186 D)DRUG

SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy women aged 18 to 35 years inclusive (smokers aged up to 30 years inclusive) * No contraindications for combined oral contraceptive (COC) use * Follicular diameter of greater-equal than 15 mm on visit 6 (admission to treatment), or an observed ovulation during pretreatment cycle Exclusion Criteria: * Pregnancy or lactation- Substantial overweight, i.e., body mass index (BMI) \> 30, * Known hypersensitivity to any of the study drug ingredients * Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study, or the interpretation of the results

Locations (1)

Unnamed facility

Groningen, Netherlands

Outcomes

Primary Outcomes

Hoogland scores in cycles 2 and 3

Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12)

Secondary Outcomes

Follicle size

Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12

Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone

Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12

Endometrial thickness

Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12

Cervical mucus

Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12

Data from ClinicalTrials.gov

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