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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00673686
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Contraceptives, Oral Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) Drug: Yasminelle (SH T 00186 D) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2004
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 2 Drug: Yasminelle (SH T 00186 D)
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
Experimental: Arm 1 Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
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


Outcome Measures
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Primary Outcome Measures :
  1. Hoogland scores in cycles 2 and 3 [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12) ]

Secondary Outcome Measures :
  1. Follicle size [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ]
  2. Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ]
  3. Endometrial thickness [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ]
  4. Cervical mucus [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673686


Locations
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Netherlands
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications of Results:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00673686    
Other Study ID Numbers: 91377
308382
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Keywords provided by Bayer:
Oral contraceptive
Ovulation
Missing pills
Intake compliance
Cycle control
Additional relevant MeSH terms:
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Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs