Ovulation Inhibition of Two 4-Phasic Oral Contraceptive Regimens

Original Study ID : 91271

Secondary ID : 307300

NCT ID : NCT00805415

Brief Title : Ovulation Inhibition of Two 4-Phasic Oral Contraceptive Regimens

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

Brief Summary :

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

Source : Bayer

Overall Status : Completed

Start Date : March 2003

End Date : February 2004

Completion Date : February 2004

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Enrollment : 200

Verification Date : November 2008

First Received Date : December 8, 2008

Trial Eligibility

Criteria :
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

Minimum Age : 18 Years

Maximum Age : 35 Years

Healthy Volunteers : Accepts He

Facilities

City : Berlin

Zip Code : 13342

Country : Germany

City : Groningen

Zip Code : 9713 GZ

Country : Netherlands

OutComes

Primary OutComes

Measure : Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)

Time Frame : Treatment cycles 2 and 3

Safety issue : No

Secondary OutComes

Measure : Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)

Time Frame : Treatment cycles 2 or 3

Safety issue : No

Measure : Measurements of endometrial thickness

Time Frame : Treatment cycles 2 and 3

Safety issue : No

Measure : Visibility of cervical mucus

Time Frame : Treatment cycles 2 and 3

Safety issue : No

Measure : Ovarian activity (Hoogland score)

Time Frame : Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3

Safety issue : No

Measure : Measurements of follicle size

Time Frame : Treatment cycles 2 and 3

Safety issue : No

Measure : Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)

Time Frame : Treatment cycles 2 and 3

Safety issue : No

Measure : Compliance

Time Frame : Throughout whole study

Safety issue : No

Measure : 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

Safety issue : Yes

Interventions

Type : Drug

Name : EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Description : Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg

Type : Drug

Name : EV/DNG (SH T00658L)

Description : Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg

Clinical Trial Name - Ovulation Inhibition of Two 4-Phasic Oral Contraceptive Regimens