Clinical trial NCT00302666: Bleeding Pattern 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Contraceptive
Keywords: Contraception, Bleeding pattern
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-03-14
Enrollment: 1315
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Bleeding pattern
Secondary outcomes:
measure: Safety, contraceptive efficacy
Other outcomes:
Locations:
city: Eberbach
country: Germany
state: Baden-Württemberg
city: Höchstadt a. d. Aisch
country: Germany
state: Bayern
city: Krumbach
country: Germany
state: Bayern
city: Neubiberg
country: Germany
state: Bayern
city: Nürnberg
country: Germany
state: Bayern
city: Dietzenbach
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Fulda
country: Germany
state: Hessen
city: Kelkheim
country: Germany
state: Hessen
city: Langen
country: Germany
state: Hessen
city: Mühlheim
country: Germany
state: Hessen
city: Neustrelitz
country: Germany
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
state: Niedersachsen
city: Hannover
country: Germany
state: Niedersachsen
city: Ronnenberg
country: Germany
state: Niedersachsen
city: Gevelsberg
country: Germany
state: Nordrhein-Westfalen
city: Gütersloh
country: Germany
state: Nordrhein-Westfalen
city: Kirchheimbolanden
country: Germany
state: Rheinland-Pfalz
city: Speyer
country: Germany
state: Rheinland-Pfalz
city: Bernburg
country: Germany
state: Sachsen-Anhalt
city: Blankenburg
country: Germany
state: Sachsen-Anhalt
city: Jessen
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Döbeln
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Wurzen
country: Germany
state: Sachsen
city: Eisenberg
country: Germany
state: Thüringen
city: Gera
country: Germany
state: Thüringen
city: Jena
country: Germany
state: Thüringen
city: Kahla
country: Germany
state: Thüringen
city: Saalfeld
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: