Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00909857 · ClinicalTrials.gov registry record · Phase 3
Effect on Primary Dysmenorrhea
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 507
- Enrollment target
NCT00909857: Completed Phase 3 study, sponsored by Bayer.
NCT00909857 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 507 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00909857, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 507 participants
- Enrollment target
Study Summary
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
Primary Outcome
Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period)
Interventions
- DRUG Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
- DRUG Ethinyl estradiol, Levonorgestrel (Miranova)
- DRUG Placebo Match to SH T00658ID
- DRUG Placebo Match to SH D593B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00909857 record still lists
NCT00909857 is an interventional study that assigns participants to a tested intervention. The registered 507 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 4 interventions - of which Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) is the first listed.
NCT00909857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00909857 about?
NCT00909857 is a clinical study titled "Effect on Primary Dysmenorrhea". To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
What is the current status of trial NCT00909857?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 507 participants. The study started on 2009-04. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00909857?
The interventions under investigation include: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (DRUG), Ethinyl estradiol, Levonorgestrel (Miranova) (DRUG), Placebo Match to SH T00658ID (DRUG), Placebo Match to SH D593B (DRUG).
Who is sponsoring clinical trial NCT00909857?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00909857's enrollment target sits among peer trials
507 739th of 2000 higher than 1,260 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06164717 · 507 participants · NA
Behavioral and Neural Characteristics of Adaptive Speech Motor Control
- NCT02115295 · 508 participants · Phase 2
Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia
- NCT04692675 · 508 participants · NA
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
- NCT07391657 · 508 participants · Phase 3
A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia