Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraceptives, Oral
Intervention: Yaz (Drug); Yasminelle (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Hoogland scores in cycles 2 and 3
Secondary outcome: Follicle sizeHormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone Endometrial thickness Cervical mucus
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Groningen 9713 GZ, Netherlands
Additional Information
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Starting date: May 2004
Ending date: February 2005
Last updated: May 6, 2008
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