A multicenter, open, randomized, parallel-group comparison to assess the safety and efficacy of the oral contraceptive SH T 00186 D (0.02 mg ethinylestradiol as betadex clathrate and 3 mg drospirenone) in two variations of an extended regimen vs. a standard regimen (24 + 4 days) in 1122 healthy female volunteers for one year, followed by a 1-year safety extension.
Phase of Trial: Phase III
Latest Information Update: 11 Feb 2013
At a glance
- Drugs Drospirenone/ethinylestradiol (Primary)
- Indications Pregnancy
- Focus Therapeutic Use
- Sponsors Bayer HealthCare Pharmaceuticals
- 12 Jul 2011 New source identified and integrated (European Clinical Trials Database)
- 09 Mar 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
- 09 Mar 2010 Actual patient number (1166) added as reported by ClinicalTrials.gov.