Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.

Bayer

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00367276

91070

305545

Details and patient eligibility

About

The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Enrollment: 221 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female requiring contraceptives.
• Aged 18 to 35 if a non-smoker, aged 18 to 30 if a smoker.
• Regular menstrual cycle (defined as duration of 28 +/- 5 days).

Exclusion criteria

• No Contraindication for OC use

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

221 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)