A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles
Information source: Bayer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy; Contraception
Intervention: BAY86-4891 (Estradiol / Drospirenone) (Drug); BAY86-4891 (Estradiol / Drospirenone) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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
Clinical Details
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
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: 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
Secondary outcome: Assessment of ovarian activity in treatment cycles 2 and 3Course of gonadotropins (FSH, LH) Endometrial growth Pharmacokinetics of estrogen and progestin in treatment cycle 3
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Berlin 13342, Germany; Recruiting
Berlin 10115, Germany; Active, not recruiting
Additional Information
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Starting date: February 2008
Ending date: December 2008
Last updated: November 3, 2008
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