A Phase 2 trial to investigate efficacy and safety of vipoglanstat in women with endometriosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gesynta Pharma AB

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

5 Dec 2025 → ongoing

Decision date (initial)

2025-11-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Dose response

To evaluate the efficacy of vipoglanstat on endometriosis-related NMPP

Conditions and MedDRA coding

Endometriosis related pain

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. Premenopausal females 18 to <45 years of age at the time of Visit 1.
2. 2. Endometriosis diagnosis confirmed and documented within the last 10 years prior to Visit 1 or during Visit 1 based on: 2a. Surgical (via direct visualization or biopsy verified) or 2b. Imaging (ie, endometriotic lesion(s) detected by transvaginal sonography or magnetic resonance imaging [MRI]).
3. 3. History of NMPP significantly affecting daily life confirmed at Visit 1.
4. 4. The participant reports moderate, severe, or very severe pain during non-menstrual days in the month prior to Visit 2, based on PGA-NMPP.

Exclusion criteria 2

1. 1. Chronic pelvic pain that is not judged to be primarily related to endometriosis (eg, chronic pelvic infection, interstitial cystitis, nerve entrapments or neuropathies, non-endometriosis-related pelvic adhesive disease, persistent symptomatic ovarian cyst [eg, dermoid], posttubal ligation, symptomatic hydrosalpinx, and vaginismus).
2. 2. Has had more than 2 surgical procedures for endometriosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Proportion of participants with at least 2.0 points, or at least 30%, reduction of mean worst NMPP NRS score, without increase in opioid rescue medication use, during non-menstrual days, from baseline to the fourth month of treatment.

Secondary endpoints 9

1. 1. Change in mean worst NMPP NRS score from baseline to the fourth month of treatment
2. 2. Proportion of participants with at least 2.0 points, or at least 30%, reduction of mean worst DYS NRS score, without increase in rescue medication use, during menstrual bleeding days, from baseline to the fourth month of treatment.
3. 3. Change in mean worst DYS NRS score from baseline to the fourth month of treatment
4. 4. Change in EHP-30 score from Visit 3 to Visit 7.
5. 5. Change in EHP-30 sexual intercourse subscale score from Visit 3 to Visit 7.
6. 6. Change in mean daily opioid rescue medication use for NMPP from baseline to the fourth month of treatment.
7. 7. Change in mean daily opioid rescue medication use for DYS from baseline to the fourth month of treatment.
8. 8. AEs.
9. 9. Safety laboratory variables (clinical chemistry, hematology, and urinalysis).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gesynta Pharma AB

Sponsor organisation

Gesynta Pharma AB

Address

Wallingatan 24, Adolf Fredrik Adolf Fredrik

City

Stockholm

Postcode

111 24

Country

Sweden

Scientific contact point

Organisation

Gesynta Pharma AB

Contact name

Eva Johnsson

Public contact point

Organisation

Gesynta Pharma AB

Contact name

Gesynta Pharma AB

Third parties 8

Locations

6 EU/EEA countries · 41 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 104 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications