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Completed

NCT Number: NCT00673686

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

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.

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Key information

Conditions

Contraceptives, Oral

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

Drug

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

Yasminelle (SH T 00186 D)

Drug

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

Primary outcomes

  1. Hoogland scores in cycles 2 and 3

    Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
May 7, 2008
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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