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.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00673686
First received: May 6, 2008
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Follicle size [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ] [ Designated as safety issue: No ]
  • Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ] [ Designated as safety issue: No ]
  • Endometrial thickness [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ] [ Designated as safety issue: No ]
  • Cervical mucus [ Time Frame: Treatment cycles 2 and 3 (treatment weeks 5-12 ] [ Designated as safety issue: No ]

Enrollment: 100
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673686

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00673686     History of Changes
Other Study ID Numbers: 91377, 308382
Study First Received: May 6, 2008
Last Updated: October 10, 2013
Health Authority: Netherlands: Dutch Health Care Inspectorate

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

Additional relevant MeSH terms:
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014