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EndometriosisPhase 3NCT05894135

Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

A Phase 3 study testing BG2109 100mg, BG2109 200mg and ABT(E2 1 mg / NETA 0.5 mg) in people with Endometriosis and Moderate to Severe Endometriosis-associated Pain, run by Bio Genuine (Shanghai) Biotech Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to demonstrate the efficacy and safety of BG2109 administered orally once daily at a dose of 100 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, while under randomized… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
BG2109 100mg, BG2109 200mg and ABT(E2 1 mg / NETA 0.5 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
540 participants
Where
1 siteChina
Study dates
14 Jul 2023to Mar 2025
Phase
Phase 3
Are there results?
None posted in the registry

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject must be a premenopausal woman aged ≥18 years.
  • The subject must have had her most recent surgical and histological diagnosis of pelvic endometriosis (laparoscopy, laparotomy, vaginal fornix or other biopsy) within 10 years and at least 2 months ago prior to screening.
  • The subject has moderate to severe EAP during the screening period defined as:
  • At the screening visit, a score of at least 2 for DYS and at least 2 for NMPP for the previous month assessed with the modified Biberoglu \& Behrman (mB\&B) scale
  • Subject is confirmed to meet the following criteria during the screening period, within 35 consecutive calendar days prior to the baseline visit:
  • Mean overall pelvic pain scores on the 0-10 NRS over the 5 days with the highest score ≥ 4; ii. At least two days with "moderate" or "severe" pain on the 0-3 VRS for pelvic pain over the days with uterine bleeding; iii. At least two days with "moderate" or "severe" pain on the 0-3 VRS for pelvic pain over the days without uterine bleeding;
  • The subject has a Body Mass Index (BMI) ≥ 18 kg/m2 at the screening visit

Who cannot join

  • The subject is pregnant or breastfeeding, or plans to become pregnant during the study treatment period.
  • The subject has a surgical history of:
  • Hysterectomy,
  • Bilateral oophorectomy,
  • Surgeries that interfere with gastrointestinal motility, pH value, or absorption (including vagotomy, enterectomy, or gastric surgery),
  • Any major abdominal surgery (including laparotomy for endometriosis) within 6 months or any interventional surgery for endometriosis (i.e. laparoscopy) performed within a period of 2 months before screening, or the subject is scheduled for a surgical abdominal procedure during the course of the study.
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  • The subject may need to take prohibited medications during the study or in the stipulated time before screening
  • The subject has a contra-indication to ABT
  • The subject has chronic pelvic pain that, in the opinion of the Investigator, is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of EAP
  • The subject has conditions that affect bone mass density (BMD) assessment
  • The subject did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis

Trial locations and contacts

1 site in 1 country.

Kevin Kong contact

021-58590032

Kevin.Kong@Bio-Genuine.com

China1 site, 1 recruiting

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai

    Congjian Xu

    Recruiting

Other trials in China

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

The objective of this study is to demonstrate the efficacy and safety of BG2109 administered orally once daily at a dose of 100 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, while under randomized treatment, in the management of moderate to severe endometriosis-associated pain (EAP) in chinese women with surgically confirmed endometriosis

Read the detailed description

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of BG2109 administered orally once daily at doses of 100 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in chinese women with surgically confirmed endometriosis.

The entire study is divided into the core stage and the extension stage, with a total duration of approximately 72 weeks. This includes the prescreening wash-out period (if applicable), screening period (approximately 5-8 weeks), core stage (24 weeks) and extension stage (28 weeks), and the safety follow-up period (approximately 12 weeks)

Being tested
BG2109 100mg, BG2109 200mg, ABT(E2 1 mg / NETA 0.5 mg), BG2109 100mg Placebo, BG2109 200mg Placebo
Medical subject headings
Endometriosis

What participants receive

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

  • BG2109 100mgDrug

    One tablet of BG2109 100mg , oral , once daily

  • BG2109 200mgDrug

    One tablet of BG2109 200mg, oral , once daily.

  • ABT(E2 1 mg / NETA 0.5 mg)Drug

    One tablet of ABT(E2 1 mg / NETA 0.5 mg), oral, once-daily

  • BG2109 100mg PlaceboDrug

    One tablet of BG2109 100mg Placebo, oral , once daily.

  • BG2109 200mg PlaceboDrug

    One tablet of BG2109 200mg Placebo, oral , once daily.

  • ABT PlaceboDrug

    One tablet of ABT Placebo, oral, once-daily

Study groups in NCT05894135
Study groupRoleWhat they receive
BG2109 100 mg groupExperimentalNot described
Receives: Drug: BG2109 100mg; Drug: BG2109 200mg Placebo; Drug: ABT Placebo
BG2109 200 mg +ABT groupExperimentalNot described
Receives: Drug: BG2109 200mg; Drug: ABT(E2 1 mg / NETA 0.5 mg); Drug: BG2109 100mg Placebo
Placebo groupPlacebo comparatorNot described
Receives: Drug: BG2109 100mg Placebo; Drug: BG2109 200mg Placebo; Drug: ABT Placebo

What is being measured

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

  1. Dysmenorrhea (DYS) response rate at Week 12

    responders are defined as those with a significant decrease in mean DYS score measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse) compared to baseline, with decreased or stable analgesic use for EAP

    Measured: Week 12

  2. Non-menstrual pelvic pain (NMPP) response rate at Week 12

    responders are defined as those with a significant decrease in mean NMPP score measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse) compared to baseline, with decreased or stable analgesic use for EAP

    Measured: Week 12

Secondary outcomes (5)

  1. Change of the interference of pain with the ability to perform daily activities from the baseline at week 24

    measured using the pain dimension in Endometriosis Health Profile-30 (EHP-30)(0-100, higher scores mean worse)

    Measured: Week 24

  2. Change of the mean overall pelvic pain(OPP) score from the baseline at week 24

    measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)

    Measured: Week 24

  3. Change of the mean DYS score from the baseline at week 24

    measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)

    Measured: Week 24

  4. Change of the mean NMPP score from the baseline at week 24

    measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)

    Measured: Week 24

  5. Ratio of subjects who do not use analgesics to treat EAP at week 24

    Measured: Week 24

Timeline

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

  1. First posted8 Jun 2023
  2. Study start14 Jul 2023
  3. Primary completionJun 2024 (estimated)
  4. Study completionMar 2025 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05894135
Sponsor's protocol ID
BG2109-AB-301
Status last verified
Jul 2023
First submitted
9 May 2023
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BG2109 100mg, BG2109 200mg and ABT(E2 1 mg / NETA 0.5 mg) in people with Endometriosis and Moderate to Severe Endometriosis-associated Pain, run by Bio Genuine (Shanghai) Biotech Co., Ltd. at 1 site 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

Contact Kevin Kong (021-58590032, Kevin.Kong@Bio-Genuine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dysmenorrhea (DYS) response rate at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. 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 NCT05894135.

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 27 Jul 2023.

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