Clinical trial
Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
NCT00461305 · Bayer, Industry · Completed
Key facts
| NCT number | NCT00461305 |
|---|---|
| Title | Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea |
| Official title | A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and… |
| Lead sponsor | Bayer, Industry |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | Dysmenorrhea |
| Intervention type | Drug |
| Interventions | DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles) |
| Enrollment | 420 |
| Start date | Feb 1, 2007 |
| Primary completion | Jan 1, 2009 |
| Completion | Aug 1, 2009 |
| First posted | Apr 18, 2007 |
| Last update posted | Jan 24, 2013 |
| Countries | Japan |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: