Bleeding Pattern Study - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00302666

Purpose

The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.

Condition	Intervention	Phase
Oral Contraceptive	Drug: Valette (Dienogest/EE30, BAY86-5038)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Dienogest

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Bleeding pattern

Secondary Outcome Measures:

Safety, contraceptive efficacy

Enrollment:	1315
Study Start Date:	June 2003
Study Completion Date:	February 2005

Arms	Assigned Interventions
Arm 1: Sham Comparator	Drug: Valette (Dienogest/EE30, BAY86-5038) Oral contraceptive extended cycles
Arm 2: Sham Comparator	Drug: Valette (Dienogest/EE30, BAY86-5038) Oral contraceptive conventional cycles

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy female volunteers aged between 18 and 40 years requiring contraception.

Exclusion Criteria:

Pregnancy or lactation.
Any conditions that might interfere with the outcome as well as all contraindications for OC use.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302666

Show 48 Study Locations

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

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91227, 306903
Study First Received:	February 23, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00302666 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Contraception, Bleeding pattern

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Ethinyl Estradiol
Healthy
Contraceptive Agents, Male
Hemorrhage
Hormones
Dienogest

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female

Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Contraceptive Agents, Male
Pharmacologic Actions
Therapeutic Uses
Dienogest

ClinicalTrials.gov processed this record on September 02, 2009