Evidence map›Paper›PMID 35947347›Full record

Trial reportAdvances in therapy2022

Assessment of Two Formulations of Triptorelin in Chinese Patients with Endometriosis: A Phase 3, Randomized Controlled Trial.

Xiaoyan Li, Huaifang Li, Hong Shi, Xiaomao Li, Renfeng Zhou, Dan Lu, Yunlang Cai, Yingfang Zhou, Patrick Cabri, Xiaofeng Shi and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03232281 (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), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03232281 phase3completednot on this map

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

TypeinterventionalSponsorIpsenRan2017 to 2019Enrolled300ConditionsEndometriosisArmsTriptorelin Pamoate PR 3-month, Triptorelin Acetate PR 1-month
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 3 countries.

Xiaoyan LiDepartment of Obstetrics and Gynecology, National Clinical Research Center for Obstetric and Gynecologic Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, No 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.
Huaifang LiTongji Hospital Affiliated to Tongji University, Shanghai, China.
Hong ShiThe First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
Xiaomao LiThe Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Renfeng ZhouGuangxi Zhuang Autonomous Region People's Hospital, Guangxi, China.
Dan LuBeijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.
Yunlang CaiZhongda Hospital, Southeast University, Nanjing, China.
Yingfang ZhouPeking University First Hospital, Beijing, China.
Patrick CabriIpsen, Boulogne-Billancourt, France.
Xiaofeng ShiIpsen (Shanghai) Innovation Pharmaceutical Co., Ltd., Shanghai, China.
Anna Pedret-DunnIpsen Bioinnovation, Abingdon, UK.
Jinhua LengDepartment of Obstetrics and Gynecology, National Clinical Research Center for Obstetric and Gynecologic Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, No 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China. lengjenny@vip.sina.com.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNBeijing Obstetrics and Gynecology Hospital · CNDalian Medical University · CNIpsen (France) · FRIpsen (United Kingdom) · GBPeking Union Medical College Hospital · CNPeking University First Hospital · CNThe People's Hospital of Guangxi Zhuang Autonomous Region · CNTongji University · CNZhongda Hospital Southeast University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis phase 3, randomized, open-label, active-controlled, multicenter study investigated the efficacy of triptorelin pamoate prolonged-release (PR) 3-month in Chinese patients with endometriosis by demonstrating the noninferiority of the 3-month formulation to the standard of care, triptorelin acetate PR 1-month.

methodsThe trial was conducted in 24 clinical centers in China, and included 300 Chinese women (18-45 years) with endometriosis and regular menstrual cycles who required treatment with a gonadotropin-releasing hormone agonist for 6 months. One group of patients (n = 150) was treated with triptorelin pamoate PR 3-month (15 mg per injection, once every 12 weeks), and the other (n = 150) with triptorelin acetate PR 1-month (3.75 mg per injection, once every 4 weeks). The primary outcome measure was the proportion of patients with estradiol (E2) concentrations suppressed to castration levels (≤ 184 pmol/L, or 50 pg/mL) after 12 weeks of treatment.

resultsTriptorelin pamoate PR 3-month was noninferior to triptorelin acetate PR 1-month for the treatment of endometriosis: over 98% of patients in both groups were chemically castrated at week 12. Both formulations were also equally efficacious in reducing endometriosis-associated pelvic pain, and reducing serum concentrations of E2, luteinizing hormone, and follicle-stimulating hormone over time. No new safety concerns were identified.

conclusionTriptorelin pamoate PR 3-month is a valid alternative to triptorelin acetate PR 1-month for the treatment of Chinese women with endometriosis, with fewer injections and a potentially lower burden of care.

trial registrationNCT03232281.

Indexed as

EndometriosisTriptorelin PamoateAcetatesFemaleFollicle Stimulating HormoneGonadotropin-Releasing HormoneHumansLuteinizing HormoneAcetatesFollicle Stimulating HormoneGonadotropin-Releasing HormoneLuteinizing HormoneTriptorelin PamoateChinese womenEndometriosisTriptorelin pamoate

Identifiers

PMID35947347
PMCPMC9464738
OpenAlexW4292448979

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.