A Double-Blind, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen / Progestogen Regimens in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles - Full Text View

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
Healthy Contraception	Drug: Estradiol / Drospirenone	Phase II

MedlinePlus related topics:

Birth Control

ChemIDplus related topics:

Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate 1,2-Dihydrospirorenone

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	116
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
Arm 1: Experimental n/a	Drug: Estradiol / Drospirenone Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
Arm 2: Experimental n/a	Drug: 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

Contacts


Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com

Locations


Germany
	Bayer Clinical Research Center	Recruiting
	Berlin, Germany

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Study Director Bayer Study Manager	Bayer

More Information

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Responsible Party:	( Bayer Schering Pharma, Clinical Pharmacology, Therapeutic Area Head )
Study ID Numbers:	91697, EudraCT 2007-004544-73, 311623
First Received:	February 28, 2008
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00631124
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration

Keywords provided by Bayer:

Antibaby-Pille,

Schwangerschaftsverhütung

Study placed in the following topic categories:

Benzoates

Estradiol 3-benzoate

Estradiol valerate

Drospirenone

Estradiol 17 beta-cypionate

Healthy

Polyestradiol phosphate

Estradiol

Additional relevant MeSH terms:

Estrogens

Aldosterone Antagonists

Contraceptive Agents

Hormone Antagonists

Therapeutic Uses

Physiological Effects of Drugs

Contraceptive Agents, Female

Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents

Hormones

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008

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