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

Contraceptives, Oral Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673686
• Other study ID #: 91377
• Secondary ID: 308382
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2008
• Last updated: October 10, 2014
• Start date: May 2004
• Est. completion date: February 2005

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraceptives, Oral

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hoogland scores in cycles 2 and 3		Treatment cycles 2 and 3 (treatment weeks 5-12)	No
Secondary	Follicle size		Treatment cycles 2 and 3 (treatment weeks 5-12	No
Secondary	Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone		Treatment cycles 2 and 3 (treatment weeks 5-12	No
Secondary	Endometrial thickness		Treatment cycles 2 and 3 (treatment weeks 5-12	No
Secondary	Cervical mucus		Treatment cycles 2 and 3 (treatment weeks 5-12	No

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