Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D

Study Overview
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Brief Summary
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In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on contraceptive robustness of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.

Official Title
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Single Center, Double-blind, Randomized Study to Compare the Effect of SH T 00186 D on Follicular Development in a 24-day Regimen Versus a 21-day Regimen in Healthy Female Volunteers

Conditions
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Contraceptives, Oral

Intervention / Treatment
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* Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
* Drug: Yasminelle (SH T 00186 D)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women aged 18 to 35 years inclusive (smokers aged up to 30 years inclusive) No contraindications for combined oral contraceptive (COC) use Follicular diameter of greater-equal than 15 mm on visit 6 (admission to treatment), or an observed ovulation during pretreatment cycle Exclusion Criteria: Pregnancy or lactation- Substantial overweight, i.e., body mass index (BMI) > 30, Known hypersensitivity to any of the study drug ingredients Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study, or the interpretation of the results

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 2<br> | Drug: Yasminelle (SH T 00186 D)<br>* SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each<br>|
| Experimental: Arm 1<br> | Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)<br>* SH T 00186 D in a 24-day regimen, i.e., 24 verum tablets, 4 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hoogland scores in cycles 2 and 3 |  | Treatment cycles 2 and 3 (treatment weeks 5-12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follicle size |  | Treatment cycles 2 and 3 (treatment weeks 5-12 | 
| Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone |  | Treatment cycles 2 and 3 (treatment weeks 5-12 | 
| Endometrial thickness |  | Treatment cycles 2 and 3 (treatment weeks 5-12 | 
| Cervical mucus |  | Treatment cycles 2 and 3 (treatment weeks 5-12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral contraceptive, Ovulation, Missing pills, Intake compliance, Cycle control