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Recruiting NCT06963177

A Phase IIa Clinical Study to Assess the Efficacy and Safety of GenSci048 in Patients With Moderate to Severe Endometriosis-Associated Pain

Phase II Interventional Endometriosis-related Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GenSci048, Placebo.
Who it may be relevant to
Registry conditions: Endometriosis-related Pain. Basic parameters: 18 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Assess the Efficacy and Safety of GenSci048 in Patients With Moderate to Severe Endometriosis-Associated Pain

Overview

This study is designed to evaluate the safety and efficacy of GenSci048 for moderate to severe endometriosis-associated pain treatment.

Interventions

  • Drug GenSci048
    Administered SC.
  • Drug Placebo
    Administered SC.

Primary outcome measures

  • Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) [Time frame: baseline, week 24]
  • Change of non-menstrual pelvic pain (NMPP) measured by Numeric Rating Scale (NRS) [Time frame: baseline, week 24]
Secondary outcome measures (4)
  • Change of DYS, NMPP, and dyspareunia (DYSP) measured by Numeric Rating Scale (NRS). The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. [Time frame: 52 weeks]
  • Permitted rescue medication use. [Time frame: 52 weeks]
  • Patient Global Impression of Change, Patient Global Impression of Change (minimum 1, maximum 7, higher score mean a worse outcome). [Time frame: Week 12、Week 24、Week 52]
  • Adverse Event [Time frame: up to approximately 56 weeks]

Eligibility criteria

Inclusion criteria

  • Pre-menopausal female participants, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
  • Participants must have a diagnosis of endometriosis within 10 years before screening.
  • Have moderate to severe endometrial related pain.
  • Have at least one regular, natural menstrual cycles (ranging from 21 to 35 days (inclusive)) before and during the screening period.
  • Agree to switch from her usual analgesic medication to only that which is permitted in the study from the screening period to the end of treatment and agree to stop using other treatments for endometriosis.
  • Agree to use non-hormonal contraception from the time of signing the informed consent until 4 weeks after the last dose of the study medication.

Exclusion criteria

  • Participants who have previously received hysterectomy and/or bilateral oophorectomy, or plan to undergo these procedures during the study period.
  • Participants who suffer from chronic pelvic and/or non-pelvic pain that is not caused by EM and require chronic analgesia or other chronic treatment, which is expected to affect the assessment of EAP.
  • Pelvic ultrasound screening indicating a need for surgery or suspicion of malignancy.
  • Participants with abnormal and undiagnosed vaginal and/or uterine bleeding within 3 months prior to screening.
  • Participants who plan to schedule elective surgery during the study; or those who have had a surgery within 4 months prior to screening and need ongoing pain management.
  • History of severe depression or post-traumatic stress disorder within the two years prior to screening, or history of any other severe mental disorder at any time.
  • History of drug or alcohol abuse within the six months prior to screening.
  • Participants who have participated in any other interventional clinical trial (including clinical trials of drugs and devices) within 1 month prior to screening.
  • Have used a prohibited long-acting anesthetic or immediate-release anesthetic for more than 2 consecutive weeks for the treatment of endometriosis associated pain in the 6 months prior to screening.
  • Participant is pregnant, breast feeding, or planning a pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Identifiers

NCT: NCT06963177 · GenSci048-205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗