- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00673686
Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D
October 10, 2014 updated by: Bayer
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Groningen, Netherlands, 9713 GZ
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 2
|
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
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Experimental: Arm 1
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hoogland scores in cycles 2 and 3
Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12)
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Treatment cycles 2 and 3 (treatment weeks 5-12)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Follicle size
Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12
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Treatment cycles 2 and 3 (treatment weeks 5-12
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Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone
Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12
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Treatment cycles 2 and 3 (treatment weeks 5-12
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Endometrial thickness
Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12
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Treatment cycles 2 and 3 (treatment weeks 5-12
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Cervical mucus
Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12
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Treatment cycles 2 and 3 (treatment weeks 5-12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Primary Completion (Actual)
February 1, 2005
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
May 6, 2008
First Submitted That Met QC Criteria
May 6, 2008
First Posted (Estimate)
May 7, 2008
Study Record Updates
Last Update Posted (Estimate)
October 13, 2014
Last Update Submitted That Met QC Criteria
October 10, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91377
- 308382
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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