Status:
COMPLETED
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
Lead Sponsor:
Ipsen
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief 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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03232281
Start Date
July 28 2017
End Date
November 16 2019
Last Update
October 14 2021
Active Locations (24)
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1
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, China, 100006
2
Peking University First Hospital
Beijing, China, 100034
3
Chinese PLA General Hospital
Beijing, China, 100039
4
Peking University People's Hospital
Beijing, China, 100044