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:	Prevention, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
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
Arm 1: Experimental	Drug: BAY86-4891 (Estradiol / Drospirenone) Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
Arm 2: Experimental	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:

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Head Clinical Pharmacology )
Study ID Numbers:	91697, EudraCT :2007-004544-73, 311623
Study First Received:	February 28, 2008
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00631124 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Contraception

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate
Reproductive Control Agents

Hormones
Estradiol
Pharmacologic Actions
Aldosterone Antagonists
Therapeutic Uses
Estradiol 3-benzoate
Drospirenone
Polyestradiol phosphate

ClinicalTrials.gov processed this record on February 08, 2010