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EndometriosisPhase 3NCT03232281

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 3 study testing Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month in people with Endometriosis, run by Ipsen at 24 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometriosis
What is being tested?
Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
24 sitesChina
Study dates
28 Jul 2017to 16 Nov 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, 100006

  • Peking University First Hospital

    Beijing, 100034

  • Chinese PLA General Hospital

    Beijing, 100039

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100069

  • Peking University Third Hospital

    Beijing, 100191

  • Peking Union Medical College Hospital

    Beijing, 100730

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, 116011

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, 510235

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510630

  • Hainan General Hospital

    Haikou, 570311

  • Women's Hospital, School of Medicine Zhejiang University

    Hangzhou, 310006

  • Sir Run Run Shaw Hospital school of medicine, Zhejiang University

    Hangzhou, 310020

  • Nanjing Maternity and Child Health Care Hospital

    Nanjing, 210004

  • Zhongda Hospital, Southeast University

    Nanjing, 210009

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, 530021

  • Obstetrics and Gynaecology Hospital of Fudan University

    Shanghai, 200011

  • Shanghai Tongji Hospital

    Shanghai, 200065

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 050000

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300211

  • Northern Jiangsu People's Hospital

    Yangzhou, 225001

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004

Other trials in China

About this study

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

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
Endometriosis
Being tested
Triptorelin Pamoate PR 3-month, Triptorelin Acetate PR 1-month
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triptorelin Pamoate PR 3-monthDrug

    Also called Triptorelin pamoate for injection 15 mg

    15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).

  • Triptorelin Acetate PR 1-monthDrug

    Also called Diphereline 3.75 mg

    3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)

Study groups in NCT03232281
Study groupRoleWhat they receive
Triptorelin pamoate PR 3-monthExperimentalSubjects received 15 mg triptorelin pamoate per injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
Receives: Drug: Triptorelin Pamoate PR 3-month
Triptorelin acetate PR 1-monthActive comparatorSubjects received 3.75 mg triptorelin acetate per injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
Receives: Drug: Triptorelin Acetate PR 1-month

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at 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.

    Measured: Week 12

Secondary outcomes (7)

  1. Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at 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.

    Measured: Weeks 4 and 8

  2. Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at 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.

    Measured: Weeks 4, 8 and 12

  3. Change From Baseline in Endometriosis-associated Pelvic Pain at 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.

    Measured: Baseline (Day 1) and Weeks 4, 8 and 12

  4. Mean E2 Concentration at Weeks Baseline and 4, 8 and 12

    The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.

    Measured: Baseline (Day 1) and Weeks 4, 8 and 12

  5. Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12

    The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.

    Measured: Baseline (Day 1) and Weeks 4, 8 and 12

  6. Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12

    The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.

    Measured: Baseline and Weeks 4, 8 and 12

  7. Median Time to Menses Recovery

    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.

    Measured: Baseline (Day 1) up to Week 40 (end of study visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2017
  2. Study start28 Jul 2017
  3. Primary completion17 May 2019
  4. Study completion16 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03232281
Sponsor's protocol ID
D-CN-52014-220
Status last verified
Sep 2021
First submitted
25 Jul 2017
Last updated
14 Oct 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li X, Li H, Shi H, Li X, Zhou R, Lu D, Cai Y, Zhou Y, Cabri P, Shi X, Pedret-Dunn A, Leng J. Assessment of Two Formulations of Triptorelin in Chinese Patients with Endometriosis: A Phase 3, Randomized Controlled Trial. Adv Ther. 2022 Oct;39(10):4663-4677. doi: 10.1007/s12325-022-02264-5. Epub 2022 Aug 10.

    PubMed 35947347

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month in people with Endometriosis, run by Ipsen at 24 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03232281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.

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