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NCT Number: NCT07260669

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

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

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Key information

Conditions

Endometriosis Dysmenorrhea Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

MHAT Puls AD, Blagoevgrad, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premenopausal females 18 to < 45 years of age at the time of Visit 1.
  • Endometriosis diagnosis confirmed and documented within the last 10 years prior to Visit 1 or during Visit based on:
  • 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.
  • The participant reports moderate, severe, or very severe pain during non-menstrual days in the month prior to Visit 2, based on patient global assessment NMPP.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

  5. Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment

    Time frame: Baseline to 4 months

  6. Change in Mean Daily Opioid Rescue Medication Use for NMPP from Baseline to Fourth Month of Treatment

    Time frame: Baseline to 4 months

  7. Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment

    Time frame: Baseline to 4 months

  8. Number of Participants with Adverse Events

    Time frame: Up to 10 months

    Any clinically significant changes in laboratory variables, including clinical chemistry, hematology, and urinalysis will be reported as adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

CMO VP Clinical Development

CONTACT

[email protected]

+46 762 788 389

Sponsors and collaborators

Lead sponsor

Gesynta Pharma AB

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of 2 Doses of Vipoglanstat in Patients With Moderate to Severe Endometriosis-related Pain - the NOVA Trial

Acronym: NOVA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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