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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

Tracking Information
First Submitted Date  ICMJE May 6, 2008
First Posted Date  ICMJE May 7, 2008
Last Update Posted Date October 13, 2014
Study Start Date  ICMJE May 2004
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
Hoogland scores in cycles 2 and 3 [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00673686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
  • Follicle size [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ]
  • Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ]
  • Endometrial thickness [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ]
  • Cervical mucus [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Contraceptives, Oral
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm 2
    Intervention: Drug: Yasminelle (SH T 00186 D)
  • Experimental: Arm 1
    Intervention: Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Publications * Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 μg compared with a 21/7 regimen of desogestrel 150 μg/ethinylestradiol 20 μg: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2014)
105
Original Actual Enrollment  ICMJE
 (submitted: May 6, 2008)
100
Actual Study Completion Date  ICMJE February 2005
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00673686
Other Study ID Numbers  ICMJE 91377
308382
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP