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NCT00754065 · ClinicalTrials.gov registry record · Phase 3
To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 409
- Enrollment target
NCT00754065 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 409 participants.
The verdict
NCT00754065, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 409 participants
- Enrollment target
Study Summary
The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.
Interventions
- DRUG Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
- DRUG Ortho Tri Cyclen Lo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 409 participants |
| Start Date | 2008-09-08 |
| Est. Completion | 2011-05-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00754065
The ClinicalTrials.gov registry entry for NCT00754065 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 409 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) is the first listed.
NCT00754065 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00754065 about?
NCT00754065 is a clinical study titled "To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)". The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethin...
What is the current status of trial NCT00754065?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 409 participants. The study started on 2008-09-08. Estimated completion is 2011-05-10.
What interventions are being tested in trial NCT00754065?
The interventions under investigation include: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (DRUG), Ortho Tri Cyclen Lo (DRUG).
Who is sponsoring clinical trial NCT00754065?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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