Health Trials

A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis

ConditionEndometriosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorGesynta Pharma AB

About this trial

The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Premenopausal females 18 to < 45 years of age at the time of Visit 1.

Surgical (via direct visualization or biopsy verified) or

Imaging (ie, endometriotic lesion(s) detected by transvaginal sonography or magnetic resonance imaging [MRI].

History of NMPP significantly affecting daily life confirmed at Visit 1.

Disqualifiers

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).

Has had more than 2 surgical procedures for endometriosis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vipoglanstat

    Drug

    Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.

  • Placebo

    Drug

    Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.

Treatment groups

190 Participants
are divided into 3 treatment groups
Group A: Dose A VipoglanstatExperimental treatment 1 intervention
Group B: Dose B VipoglanstatExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment

Time frame
Baseline to 4 months

Secondary outcomes

1

Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment

Time frame
Baseline to 4 months
2

Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment

Time frame
Baseline to 4 months
3

Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment

Time frame
Baseline to 4 months
4

Change in Endometriosis Health Profile 30 Item Patient Reported Outcome (EHP-30) Score from Baseline to End of Treatment

Time frame
Baseline to 4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gesynta Pharma AB

Lead sponsor

Source ClinicalTrials.gov
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