Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

Phase 2

Completed

• Conditions: Ovulation Inhibition
• Interventions: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K); Drug: EV/DNG (SH T00658L)

• Registration Number: NCT00805415
• Lead Sponsor: Bayer

Brief Summary

The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-14
• Last Update Posted: 2011-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 209

Inclusion Criteria

• Healthy women willing to use non-hormonal methods of contraception

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Exclusion Criteria

• Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	EV/DNG (Qlaira, BAY86-5027, SH T00658K)	-
Arm 2	EV/DNG (SH T00658L)	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)	Treatment cycles 2 and 3

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)	Treatment cycles 2 or 3
Measurements of endometrial thickness	Treatment cycles 2 and 3
Visibility of cervical mucus	Treatment cycles 2 and 3
Ovarian activity (Hoogland score)	Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3
Measurements of follicle size	Treatment cycles 2 and 3
Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)	Treatment cycles 2 and 3
Compliance	Throughout whole study
Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signs	Various timepoint throughout the study

Trial Locations

Locations (2)

Dinox B.V.; 🇳🇱 Groningen, Netherlands

Dinox GmbH Berlin; 🇩🇪 Berlin, Germany