NCT00220324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

First QC Date

September 16, 2005

Last Update Submit

April 2, 2015

Conditions

Contraception

Keywords

Contraception

Outcome Measures

Primary Outcomes (1)

  • Unadjusted Pearl Index

    After 13 cycles of intake

Secondary Outcomes (4)

  • 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

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Minisiston (SH D00342A)

Interventions

Minisiston (SH D00342A)DRUG

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

Arm 1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women requiring contraception

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Unknown Facility

Hanover, Lower Saxony, 30159, Germany

Location

Unknown Facility

Dresden, Saxony, 01067, Germany

Location

Unknown Facility

Dresden, Saxony, 01099, Germany

Location

Unknown Facility

Dresden, Saxony, 01108, Germany

Location

Unknown Facility

Dresden, Saxony, 01324, Germany

Location

Unknown Facility

Großpösna, Saxony, 04463, Germany

Location

Unknown Facility

Leipzig, Saxony, 04207, Germany

Location

Unknown Facility

Leipzig, Saxony, 04277, Germany

Location

Unknown Facility

Leipzig, Saxony, 04279, Germany

Location

Unknown Facility

Aschersleben, Saxony-Anhalt, 06449, Germany

Location

Unknown Facility

Burg, Saxony-Anhalt, 39288, Germany

Location

Unknown Facility

Egeln, Saxony-Anhalt, 39435, Germany

Location

Unknown Facility

Halberstadt, Saxony-Anhalt, 38820, Germany

Location

Unknown Facility

Halberstadt, Saxony-Anhalt, 38821, Germany

Location

Unknown Facility

Jessen, Saxony-Anhalt, 06917, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39126, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10179, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10247, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10409, Germany

Location

Unknown Facility

Berlin, State of Berlin, 12435, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13507, Germany

Location

Unknown Facility

Suhl, Thuringia, 98527, Germany

Location

Unknown Facility

Weida, Thuringia, 07579, Germany

Location

MeSH Terms

Interventions

Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Ethinyl EstradiolNorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorgestrelNorpregnenesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

February 1, 2004

Study Completion

November 1, 2005

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

DE(25)