Pearl Index Study With Low Dose Combined Oral Contraceptive

Prospective, Multicenter, Open-label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles to Healthy Female Volunteers

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00220324

Enrollment

840

Registered

2005-09-22

Start date

2004-02-29

Completion date

2005-11-30

Last updated

2015-04-03

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

Conditions

Contraception

Keywords

Contraception

Brief summary

The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.

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

DRUGMinisiston (SH D00342A)

Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy women requiring contraception

Exclusion criteria

* Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.

Design outcomes

Primary

Measure	Time frame
Unadjusted Pearl Index	After 13 cycles of intake

Secondary

Measure	Time frame
Adjusted Pearl Index	After 13 cycles of intake
Cumulative pregnancy rate	After 13 cycles of intake
Bleeding pattern	After 13 cycles of intake
Cycle control	After 13 cycles of intake

Countries

Germany

Outcome results

None listed

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