A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles

Bayer

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Drug: BAY86-4891 (Estradiol / Drospirenone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631124

2007-004544-73 (EudraCT Number)

91697

311623 (Other Identifier)

Details and patient eligibility

About

Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles

Enrollment: 103 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female volunteers,
• Age 18 - 35 years

Exclusion criteria

• Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease)
• Regular intake of medication
• Clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
• Anovulatory pre-treatment cycle

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

103 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: BAY86-4891 (Estradiol / Drospirenone)

Drug: BAY86-4891 (Estradiol / Drospirenone)

Arm 2

Experimental group

Treatment:

Drug: BAY86-4891 (Estradiol / Drospirenone)

Drug: BAY86-4891 (Estradiol / Drospirenone)