Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Yaz
  • SH T 00186 D in a 24-day regimen, i.e., 24 verum tablets, 4 placebo tablets Dose: 0.02 mg EE, 3 mg DRSP Mode of administration: Oral, 1 tablet daily Duration of treatment: 3 cycles of 28 days each
• Drug: Yasminelle
  • SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSP Mode of administration: Oral, 1 tablet daily Duration of treatment: 3 cycles of 28 days each

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 2
• Experimental: Arm 1

Primary Measures

• Hoogland scores in cycles 2 and 3
  • Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12)
    Safety Issue?: No

Secondary Measures

• Follicle size
  • Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12
    Safety Issue?: No
• Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone
  • Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12
    Safety Issue?: No
• Endometrial thickness
  • Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12
    Safety Issue?: No
• Cervical mucus
  • Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00673686

Study ID Number: 91377

ClinicalTrials.gov Identifier: NCT00673686

Health Authority: Netherlands: Dutch Health Care Inspectorate

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