Bleeding Pattern Study

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00302666

Enrollment

1315

Registered

2006-03-14

Start date

2003-06-30

Completion date

2005-02-28

Last updated

2009-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Contraceptive

Keywords

Contraception, Bleeding pattern

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.

Interventions

DRUGValette (Dienogest/EE30, BAY86-5038)

Oral contraceptive extended cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bleeding pattern	—

Secondary

Measure	Time frame
Safety, contraceptive efficacy	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026