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

Bayer2 sites in 2 countries209 target enrollmentMarch 2003

Overview

Phase: Phase 2
Intervention: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
Conditions: Ovulation Inhibition
Sponsor: Bayer
Enrollment: 209
Locations: 2
Primary Endpoint: Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)
Status: Completed
Last Updated: 14 years ago

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

Registry

clinicaltrials.gov

Start Date

March 2003

End Date

February 2004

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

•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

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

Intervention: EV/DNG (SH T00658L)

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

Time Frame: Treatment cycles 2 and 3

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)