Trial Condition(s):
Contraception
Pearl Index study with low dose combined oral contraceptive
Bayer Identifier:
91313
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 | |
|---|---|
Locations Frauenarztpraxis Fr. Dr. N. Reich Berlin, Germany, 10179 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Hr. Dr. G. Merder Berlin, Germany, 10247 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Fr. Dr. Susanne Plettig Berlin, Germany, 10409 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. J. Schmidt-Pich Hannover, Germany, 30159 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. G. Gollnick Dresden, Germany, 01099 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. R. Dziambor Dresden, Germany, 01108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Sven Hildebrandt Dresden, Germany, 01324 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Bernd Pittner Leipzig, Germany, 04207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. G. Quick Leipzig, Germany, 04279 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. C. Hösemann Großpösna, Germany, 04463 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. H. Thelen Jessen, Germany, 06917 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. K. Müller Aschersleben, Germany, 06449 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. B. Gerecke Halberstadt, Germany, 38821 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. E. Schwarzenau Magdeburg, Germany, 39112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. R. Guenther Magdeburg, Germany, 39120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Fr. Dr. S. Gramatte Berlin, Germany, 12435 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. I. Hannig Berlin, Germany, 12435 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. K. Maar Berlin, Germany, 13507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. E. Gotzmann Dresden, Germany, 01067 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. U. Schlenk Dresden, Germany, 01324 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Fr. Dr. Ulrike Krieg Leipzig, Germany, 04207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. G. Förster Leipzig, Germany, 04277 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. C. Voitl Aschersleben, Germany, 06449 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. A. Prell Halberstadt, Germany, 38820 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. B. Schrader Halberstadt, Germany, 38820 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. H.-J. Ahrendt Magdeburg, Germany, 39126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Hr. Dr. Bernd Hennig Burg, Germany, 39288 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dipl. med. Michael Stellmacher Burg, Germany, 39288 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dipl. med. Elke Leidenfrost Weida, Germany, 07579 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. B. Hauck Suhl, Germany, 98527 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. K. Zettl Egeln, Germany, 39435 | 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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