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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00673686

Collaborator

(none)

105

Enrollment

Location

Arms

9.1

Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraceptives, Oral	Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) Drug: Yasminelle (SH T 00186 D)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Feb 1, 2005

Actual Study Completion Date :

Feb 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Hoogland scores in cycles 2 and 3 [Treatment cycles 2 and 3 (treatment weeks 5-12)]

Secondary Outcome Measures

Follicle size [Treatment cycles 2 and 3 (treatment weeks 5-12]
Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone [Treatment cycles 2 and 3 (treatment weeks 5-12]
Endometrial thickness [Treatment cycles 2 and 3 (treatment weeks 5-12]
Cervical mucus [Treatment cycles 2 and 3 (treatment weeks 5-12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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