Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Bayer.
NCT00754065 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 409 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
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 |
What the finished NCT00754065 record still lists
NCT00754065 is an interventional study that assigns participants to a tested intervention. The registered 409 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 (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) is the first listed.
NCT00754065 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00754065's enrollment target sits among peer trials
409 911th of 2000 higher than 1,090 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
- NCT06717334 · 409 participants
A Study of Lung Cancer Screening in People With Unexplained Weight Loss
- NCT02043691 · 410 participants · NA
Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies
- NCT03042975 · 410 participants
Imaging Genetics of Laryngeal Dystonia
- NCT05730036 · 410 participants · Phase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI