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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: May 6, 2008
Last updated: October 10, 2014
Last verified: October 2014
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 Intervention Phase
Contraceptives, Oral
Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Drug: Yasminelle (SH T 00186 D)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 105
Study Start Date: May 2004
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00673686

Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00673686     History of Changes
Other Study ID Numbers: 91377
Study First Received: May 6, 2008
Last Updated: October 10, 2014

Keywords provided by Bayer:
Oral contraceptive
Missing pills
Intake compliance
Cycle control

Additional relevant MeSH terms:
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 28, 2017