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

Bayer

Status and phase: Completed; Phase 2

Conditions: Contraceptives, Oral

Treatments: Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300); Drug: Yasminelle (SH T 00186 D)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00673686

308382

91377

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 2 patient groups

Arm 2

Active Comparator group

Treatment:

Drug: Yasminelle (SH T 00186 D)

Arm 1

Experimental group

Treatment:

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