Trials / Completed
CompletedNCT03232281
Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis
A Phase III, Multicentre, Randomised, Open-label, Parallel, Active-controlled Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in Chinese female subjects with endometriosis by demonstrating the non-inferiority of triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate PR 1-month formulation injected 3 times consecutively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Triptorelin Pamoate PR 3-month | 15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections). |
| DRUG | Triptorelin Acetate PR 1-month | 3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections) |
Timeline
- Start date
- 2017-07-28
- Primary completion
- 2019-05-17
- Completion
- 2019-11-16
- First posted
- 2017-07-27
- Last updated
- 2021-10-14
- Results posted
- 2021-10-14
Locations
24 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03232281. Inclusion in this directory is not an endorsement.