Trial · NCT03232281
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
NCT03232281, Phase 3, Completed, Ipsen; results first posted 2021-10-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03232281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03232281
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT03232281
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Endometriosis
- Interventions
- Triptorelin Pamoate PR 3-month, Triptorelin Acetate PR 1-month
- First posted
- 2017-07-27
- Last updated
- 2021-10-14
- Results first posted
- 2021-10-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12 | Week 12 | Castration was defined as serum oestradiol (E2) ≤184 picomoles/litre (pmol/L) or 50 picograms/millilitre (pg/mL). The primary endpoint was evaluated based on centralised blinded bioanalysis of serum samples for E2. The percentage of subjects castrated and the 95% asymptotic confidence intervals (CIs), calculated from binomial distribution, are presented. |
| Secondary | Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8 | Weeks 4 and 8 | The percentages of subjects who were castrated at Weeks 4 and 8 where castration was defined as serum E2 ≤184 pmol/L or 50 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution. |
| Secondary | Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The percentages of subjects who were castrated at Weeks 4, 8 and 12 where castration was defined as serum E2 ≤110 pmol/L or 30 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution. |
| Secondary | Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12 | Baseline (Day 1) and Weeks 4, 8 and 12 | Endometriosis-associated pelvic pain was assessed using a 100 millimetres (mm) visual analogue scale (VAS) where subjects indicated the subjective level of their most severe endometriosis pain over the last 4 weeks by making a single vertical mark on the line ranging from 'absence of pain' (0 mm) to 'unbearable pain' (100 mm). Lower scores indicated a better outcome. Baseline was defined as the last available assessment prior to the first dose of study medication. The least squares (LS) mean change from baseline at each timepoint as measured by the VAS is presented. |
| Secondary | Mean E2 Concentration at Weeks Baseline and 4, 8 and 12 | Baseline (Day 1) and Weeks 4, 8 and 12 | The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented. |
| Secondary | Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12 | Baseline (Day 1) and Weeks 4, 8 and 12 | The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented. |
| Secondary | Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 | The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented. |
| Secondary | Median Time to Menses Recovery | Baseline (Day 1) up to Week 40 (end of study visit) | Time to menses recovery was defined as the time (in days) between the date of the last dose of study medication and the date of the first day the subject observed menstrual bleeding of the next menstrual period. Menses recovery status was assessed at all study visits from Day 1 to the end of study visit. The median time to menses recovery was analysed using the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12 | Week 12 | The per protocol set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter, and without major protocol violations/deviations affecting the primary efficacy endpoint. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8 | Weeks 4 and 8 | The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter. | percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12 | Baseline (Day 1) and Weeks 4, 8 and 12 | The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Mean E2 Concentration at Weeks Baseline and 4, 8 and 12 | Baseline (Day 1) and Weeks 4, 8 and 12 | The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter. | pmol/L | MEAN |
| SECONDARY | Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12 | Baseline (Day 1) and Weeks 4, 8 and 12 | The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter. | International Units/L (IU/L) | MEAN |
| SECONDARY | Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 | The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter. | IU/L | MEAN |
| SECONDARY | Median Time to Menses Recovery | Baseline (Day 1) up to Week 40 (end of study visit) | The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12 | Triptorelin Pamoate PR 3-month | 98.6 | 95% Confidence Interval 96.65 to 100.00 | percentage of subjects | |
| Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12 | Triptorelin Acetate PR 1-month | 99.3 | 95% Confidence Interval 97.98 to 100.00 | percentage of subjects | |
| Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8 | Triptorelin Pamoate PR 3-month | Week 4 | 98.0 | 95% Confidence Interval 95.67 to 100.00 | percentage of subjects |
| Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8 | Triptorelin Acetate PR 1-month | Week 4 | 99.3 | 95% Confidence Interval 98.03 to 100.00 | percentage of subjects |
| Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8 | Triptorelin Pamoate PR 3-month | Week 8 | 97.3 | 95% Confidence Interval 94.65 to 99.91 | percentage of subjects |
| Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8 | Triptorelin Acetate PR 1-month | Week 8 | 100.0 | 95% Confidence Interval 100.00 to 100.00 | percentage of subjects |
| Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12 | Triptorelin Pamoate PR 3-month | Week 4 | 98.0 | 95% Confidence Interval 95.67 to 100.00 | percentage of subjects |
| Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12 | Triptorelin Acetate PR 1-month | Week 4 | 99.3 | 95% Confidence Interval 98.03 to 100.00 | percentage of subjects |
| Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12 | Triptorelin Pamoate PR 3-month | Week 8 | 95.2 | 95% Confidence Interval 91.80 to 98.68 | percentage of subjects |
| Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12 | Triptorelin Acetate PR 1-month | Week 8 | 99.3 | 95% Confidence Interval 98.03 to 100.00 | percentage of subjects |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Triptorelin Pamoate PR 3-month | 150 | |
| Overall Study | STARTED | Triptorelin Acetate PR 1-month | 150 | |
| Overall Study | Received Treatment | Triptorelin Pamoate PR 3-month | 149 | |
| Overall Study | Received Treatment | Triptorelin Acetate PR 1-month | 150 | |
| Overall Study | Completed Week 12 | Triptorelin Pamoate PR 3-month | 143 | |
| Overall Study | Completed Week 12 | Triptorelin Acetate PR 1-month | 148 | |
| Overall Study | Completed Week 24 | Triptorelin Pamoate PR 3-month | 143 | |
| Overall Study | Completed Week 24 | Triptorelin Acetate PR 1-month | 144 | |
| Overall Study | COMPLETED | Triptorelin Pamoate PR 3-month | 143 | |
| Overall Study | COMPLETED | Triptorelin Acetate PR 1-month | 144 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain lower | Gastrointestinal disorders | Triptorelin Pamoate PR 3-month | 4 | 149 | 4 |
| other | Abdominal pain lower | Gastrointestinal disorders | Triptorelin Acetate PR 1-month | 13 | 150 | 19 |
| other | Abdominal pain upper | Gastrointestinal disorders | Triptorelin Pamoate PR 3-month | 6 | 149 | 7 |
| other | Abdominal pain upper | Gastrointestinal disorders | Triptorelin Acetate PR 1-month | 8 | 150 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Triptorelin Pamoate PR 3-month | 8 | 149 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Triptorelin Acetate PR 1-month | 4 | 150 | 4 |
| other | Pyrexia | General disorders | Triptorelin Pamoate PR 3-month | 6 | 149 | 6 |
| other | Pyrexia | General disorders | Triptorelin Acetate PR 1-month | 8 | 150 | 9 |
| other | Nasopharyngitis | Infections and infestations | Triptorelin Pamoate PR 3-month | 16 | 149 | 19 |
| other | Nasopharyngitis | Infections and infestations | Triptorelin Acetate PR 1-month | 24 | 150 | 30 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triptorelin Pamoate PR 3-month | 0 | 149 |
| Total, all-cause mortality | Triptorelin Acetate PR 1-month | 0 | 150 |
| Total, other adverse events | Triptorelin Pamoate PR 3-month | 132 | 149 |
| Total, other adverse events | Triptorelin Acetate PR 1-month | 135 | 150 |
| Total, serious adverse events | Triptorelin Pamoate PR 3-month | 2 | 149 |
| Total, serious adverse events | Triptorelin Acetate PR 1-month | 1 | 150 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35947347 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Triptorelin Pamoate PR 3-month vs Triptorelin Acetate PR 1-month: deaths from any cause | Trial comparisons |
| Triptorelin Pamoate PR 3-month vs Triptorelin Acetate PR 1-month: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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