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
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ClinicalTrials.gov Identifier: NCT03232281 |
Recruitment Status :
Completed
First Posted : July 27, 2017
Last Update Posted : December 20, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometriosis | Drug: Triptorelin Pamoate PR 3-month Drug: Triptorelin Acetate PR 1-month | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 28, 2017 |
Actual Primary Completion Date : | May 17, 2019 |
Actual Study Completion Date : | November 16, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: triptorelin pamoate PR 3-month |
Drug: Triptorelin Pamoate PR 3-month
15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).
Other Name: Triptorelin pamoate for injection 15 mg |
Active Comparator: triptorelin acetate PR 1-month |
Drug: Triptorelin Acetate PR 1-month
3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
Other Name: Diphereline 3.75 mg |
- Percentage of subjects castrated (E2≤184 pmol/L or 50 pg/mL) [ Time Frame: Week 12 ]Evaluated based on centralised blinded bioanalysis of serum samples for E2.
- Percentage of subjects castrated (E2≤184 pmol/L or 50 pg/mL) at Weeks 4 and 8. [ Time Frame: Week 4 and 8 ]
- Percentage of subjects castrated (E2≤110 pmol/L or 30 pg/mL) at Weeks 4, 8 and 12. [ Time Frame: Week 4, 8 and 12 ]
- Change in endometriosis-associated pelvic pain (by 10 cm visual analogue scale (VAS)) [ Time Frame: Week 4, 8 and 12 compared to baseline ]
- Oestradiol (E2) concentration [ Time Frame: Week 4, 8 and 12 ]
- Follicle stimulating hormone (FSH) concentration [ Time Frame: Week 4, 8 and 12 ]
- Luteinising hormone (LH) concentration [ Time Frame: Week 4, 8 and 12 ]
- Time to menses recovery [ Time Frame: Baseline, date of first observation of menstrual bleeding at Week 28, 32, 36 and end of study/early withdrawal (up to 40 weeks) ]Time to menses recovery will be defined as the time (in days) between date of first dose of study drug and date of first day the subject observed menstrual bleeding of the next menstrual period.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female subjects aged from 18 to 45 years inclusive at the date of informed consent.
- A history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6 months prior to the screening visit.
- A diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years prior to the screening visit.
- Requires treatment with a Gonadotrophin releasing hormone (GnRH) agonist for a period of 6 months in the judgement of the investigator.
Exclusion Criteria:
- A current history of undiagnosed abnormal genital bleeding.
- Received treatment with a GnRH agonist within 6 months prior to the screening visit.
- Received any other hormonal treatment within 3 months prior to the screening visit (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc).
- Chronic pelvic pain that is not caused by endometriosis, that would interfere with the assessment of endometriosis-associated pelvic pain.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232281

Study Director: | Ipsen Medical Director | Ipsen |
Responsible Party: | Ipsen |
ClinicalTrials.gov Identifier: | NCT03232281 |
Other Study ID Numbers: |
D-CN-52014-220 |
First Posted: | July 27, 2017 Key Record Dates |
Last Update Posted: | December 20, 2019 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Endometriosis Triptorelin Pamoate Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents |
Reproductive Control Agents Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |