check_circleStudy Completed

Contraceptives, Oral

Bayer Identifier:

91377

ClinicalTrials.gov Identifier:

NCT00673686

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to investigate the effect of missed pills on follicular development in two application regimens of SH T 00186 D

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
105
Trial Dates
May 2004 - February 2005
Phase
Phase 2
Could I Receive a placebo
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Dinox B.V.Groningen, 9713 GZ, Netherlands

Primary Outcome

  • Hoogland scores in cycles 2 and 3
    date_rangeTime Frame:
    Treatment cycles 2 and 3 (treatment weeks 5-12)
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Follicle size
    date_rangeTime Frame:
    Treatment cycles 2 and 3 (treatment weeks 5-12
    enhanced_encryption
    Safety Issue:
    no
  • Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone
    date_rangeTime Frame:
    Treatment cycles 2 and 3 (treatment weeks 5-12
    enhanced_encryption
    Safety Issue:
    no
  • Endometrial thickness
    date_rangeTime Frame:
    Treatment cycles 2 and 3 (treatment weeks 5-12
    enhanced_encryption
    Safety Issue:
    no
  • Cervical mucus
    date_rangeTime Frame:
    Treatment cycles 2 and 3 (treatment weeks 5-12
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.