Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

Ovulation Inhibition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805415
• Other study ID #: 91271
• Secondary ID: 307300
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2008
• Last updated: July 14, 2011
• Start date: March 2003
• Est. completion date: February 2004

Study information

• Verified date: July 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ovulation Inhibition

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Dinox GmbH Berlin	Berlin
Netherlands	Dinox B.V.	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)		Treatment cycles 2 and 3	No
Secondary	Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)		Treatment cycles 2 or 3	No
Secondary	Measurements of endometrial thickness		Treatment cycles 2 and 3	No
Secondary	Visibility of cervical mucus		Treatment cycles 2 and 3	No
Secondary	Ovarian activity (Hoogland score)		Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3	No
Secondary	Measurements of follicle size		Treatment cycles 2 and 3	No
Secondary	Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)		Treatment cycles 2 and 3	No
Secondary	Compliance		Throughout whole study	No
Secondary	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	Yes

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