Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00805415

First received: December 8, 2008

Last updated: July 14, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 8, 2008

Last Updated Date

July 14, 2011

Start Date ^ICMJE

March 2003

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation) [ Time Frame: Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00805415 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation) [ Time Frame: Treatment cycles 2 or 3 ] [ Designated as safety issue: No ]
Measurements of endometrial thickness [ Time Frame: Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]
Visibility of cervical mucus [ Time Frame: Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]
Ovarian activity (Hoogland score) [ Time Frame: Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]
Measurements of follicle size [ Time Frame: Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]
Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol) [ Time Frame: Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]
Compliance [ Time Frame: Throughout whole study ] [ Designated as safety issue: No ]
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 [ Time Frame: Various timepoint throughout the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

Official Title ^ICMJE

Multicenter, Open-label, Randomized, Comparative Study to Evaluate Ovulation Inhibition With Two 4-phasic Oral Contraceptive Regimens Containing Estradiol Valerate and Dienogest Applied Daily for Three Cycles to 200 Healthy Female Volunteer

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Ovulation Inhibition

Intervention ^ICMJE

Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg
Drug: EV/DNG (SH T00658L)
Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
Experimental: Arm 2
Intervention: Drug: EV/DNG (SH T00658L)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

209

Completion Date

February 2004

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy women willing to use non-hormonal methods of contraception

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

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00805415

Other Study ID Numbers ^ICMJE

91271, 307300

Has Data Monitoring Committee

Responsible Party

Therapeutic Area Head, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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