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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00631124

Purpose

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

Condition	Intervention	Phase
Contraception	Drug: BAY86-4891 (Estradiol / Drospirenone)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen 1,2-Dihydrospirorenone Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of ovarian activity in treatment cycles 2 and 3 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Course of gonadotropins (FSH, LH) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Endometrial growth [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Pharmacokinetics of estrogen and progestin in treatment cycle 3 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	116
Study Start Date:	February 2008
Study Completion Date:	December 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: BAY86-4891 (Estradiol / Drospirenone) Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
Experimental: Arm 2	Drug: BAY86-4891 (Estradiol / Drospirenone) Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631124

Locations

Germany

Berlin, Germany, 13342

Berlin, Germany, 10115

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Head Clinical Pharmacology, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00631124 History of Changes
Other Study ID Numbers:	91697, EudraCT :2007-004544-73, 311623
Study First Received:	February 28, 2008
Last Updated:	June 10, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Contraception

Additional relevant MeSH terms:

Estradiol
Polyestradiol phosphate
Estrogens
Drospirenone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012