Trial Condition(s):
Contraception
Pearl Index study with low dose combined oral contraceptive
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Frauenarztpraxis Fr. Dr. N. Reich Berlin, Germany, 10179 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Hr. Dr. G. Merder Berlin, Germany, 10247 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Fr. Dr. Susanne Plettig Berlin, Germany, 10409 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. J. Schmidt-Pich Hannover, Germany, 30159 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. G. Gollnick Dresden, Germany, 01099 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. R. Dziambor Dresden, Germany, 01108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Dr. Sven Hildebrandt Dresden, Germany, 01324 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Dr. Bernd Pittner Leipzig, Germany, 04207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. G. Quick Leipzig, Germany, 04279 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. C. Hösemann Großpösna, Germany, 04463 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. H. Thelen Jessen, Germany, 06917 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. K. Müller Aschersleben, Germany, 06449 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Dr. B. Gerecke Halberstadt, Germany, 38821 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. E. Schwarzenau Magdeburg, Germany, 39112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. R. Guenther Magdeburg, Germany, 39120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Fr. Dr. S. Gramatte Berlin, Germany, 12435 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. I. Hannig Berlin, Germany, 12435 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. K. Maar Berlin, Germany, 13507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. E. Gotzmann Dresden, Germany, 01067 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. U. Schlenk Dresden, Germany, 01324 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Fr. Dr. Ulrike Krieg Leipzig, Germany, 04207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. G. Förster Leipzig, Germany, 04277 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. C. Voitl Aschersleben, Germany, 06449 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. A. Prell Halberstadt, Germany, 38820 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. B. Schrader Halberstadt, Germany, 38820 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Prof. Dr. H.-J. Ahrendt Magdeburg, Germany, 39126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Hr. Dr. Bernd Hennig Burg, Germany, 39288 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Dipl. med. Michael Stellmacher Burg, Germany, 39288 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Dipl. med. Elke Leidenfrost Weida, Germany, 07579 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. B. Hauck Suhl, Germany, 98527 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. K. Zettl Egeln, Germany, 39435 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Unadjusted Pearl IndexTimeframe: After 13 cycles of intake
Secondary Outcome
- Adjusted Pearl IndexTimeframe: After 13 cycles of intake
- Cumulative pregnancy rateTimeframe: After 13 cycles of intake
- Bleeding patternTimeframe: After 13 cycles of intake
- Cycle controlTimeframe: After 13 cycles of intake
Additional Information
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