Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

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

Official Title
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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

Conditions
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Ovulation Inhibition

Intervention / Treatment
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* Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
* Drug: EV/DNG (SH T00658L)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)<br>* Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg<br>|
| Experimental: Arm 2<br> | Drug: EV/DNG (SH T00658L)<br>* Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation) |  | Treatment cycles 2 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Contraceptive, Ovulation Inhibition