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

NCT ID: NCT00673686

Last Updated: 2014-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2005-02-28

Brief 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.

Conditions

Contraceptives, Oral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 2

Group Type: ACTIVE_COMPARATOR

Yasminelle (SH T 00186 D)

Intervention Type: 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

Arm 1

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Groningen, , Netherlands

Countries

Netherlands

References

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 mug compared with a 21/7 regimen of desogestrel 150 mug/ethinylestradiol 20 mug: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.

Reference Type: RESULT

PMID: 21721590 (View on PubMed)

Other Identifiers

308382

Identifier Type: -

Identifier Source: secondary_id

91377

Identifier Type: -

Identifier Source: org_study_id