Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations in Healthy Young Female - Full Text View

Purpose

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

Condition	Intervention	Phase
Contraception Ovulation Inhibition	Drug: 80876395 Drug: 80876433	Phase II

MedlinePlus related topics:

Birth Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study

Official Title:	Multicenter, Open-Label, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg EE and Either 1.05 or 2.1 mg GSD in Healthy Young Female Vol. 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. [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score) [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
Course of gonadotropins (FSH, LH, P, E2) [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
Endometrial thickness [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
Follicle size [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3 [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	116
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: 80876395 transdermal patch: 0.55mg EE+2.1mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles)
Arm 2: Experimental	Drug: 80876433 transdermal patch: 0.55mg EE+1.05 mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (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:

Signed informed consent,
BMI: 18 BMI 30 kg/m²,
Healthy female volunteers,
Age 18-35 years (smoker not older than 30 years, inclusive),
Ovulatory pre-treatment cycle, at least 3 month since delivery,
Abortion or lactation before the first screening examination,
Willingness to use non-hormonal methods of contraception during entire study

Exclusion Criteria:

Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/arterial thromboembolic disease
Regular intake of medication other than OCs
Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination)
Anovulatory pre-treatment cycle

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729404

Contacts


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

Locations


Germany, Berlin / 285
		Recruiting
	Berlin, Berlin / 285, Germany, 10115
		Recruiting
	Berlin, Berlin / 285, Germany, 13342

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	91558, 2008-001198-13, 310805
First Received:	August 4, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00729404
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Female Contraception

Ovulation Inhibition

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00729404