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

Original Study ID : 91697

Secondary ID : Array

NCT ID : NCT00631124

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

Official Title : A Double-Blind, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Oral Estradiol / Drospirenone Regimens in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

Brief Summary :

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

Source : Bayer

Overall Status : Completed

Start Date : February 2008

End Date : December 2008

Completion Date : December 2008

Official Title : Phase 2

Phase : Interventional

Study Design : Prevention, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study

Enrollment : 116

Verification Date : April 2009

First Received Date : February 28, 2008

Trial Eligibility

Criteria :
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

Gender : Female

Minimum Age : 18 Years

Maximum Age : 35 Years

Healthy Volunteers : Accepts He

Facilities

City : Berlin

Zip Code : 13342

Country : Germany

City : Berlin

Zip Code : 10115

Country : Germany

OutComes

Primary OutComes

Measure : The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no

Time Frame : 12 months

Safety issue : No

Secondary OutComes

Measure : Assessment of ovarian activity in treatment cycles 2 and 3

Time Frame : 12 months

Safety issue : No

Measure : Course of gonadotropins (FSH, LH)

Time Frame : 12 months

Safety issue : No

Measure : Endometrial growth

Time Frame : 12 months

Safety issue : No

Measure : Pharmacokinetics of estrogen and progestin in treatment cycle 3

Time Frame : 12 months

Safety issue : No

Interventions

Type : Drug

Name : BAY86-4891 (Estradiol / Drospirenone)

Description : Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles

Type : Drug

Name : BAY86-4891 (Estradiol / Drospirenone)

Description : Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles

Clinical Trial Name - A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy,