Efficacy and Safety Oral Contraceptive Study

Multi-center, Open, Uncontrolled Study to Investigate the Efficacy and Safety of the Oral Contraceptive SH T 186 D Containing 0.02 mg Ethinylestradiol-b-cyclodextrin Clathrate and 3 mg Drospirenone in a 24-day Regimen for 13 Cycles in 1010 Healthy Female Volunteers

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185484

Enrollment

1113

Registered

2005-09-16

Start date

2004-03-31

Completion date

2006-01-31

Last updated

2014-12-31

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

Conditions

Contraception

Keywords

Oral contraception

Brief summary

The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age

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

DRUGYAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy woman requesting contraception * Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)

Exclusion criteria

* Any conditions might interfere study outcome

Design outcomes

Primary

Measure	Time frame
Rate of unintended pregnancies (Pearl index)	13 cycles of 28 days

Secondary

Measure	Time frame
Physical and gynecological examination	screening, cycle 6 and final examination
Vital signs	each visit
Body weight	each visit
Cervical smear	each visit

Outcome results

None listed

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