EndometriosisPhase 2NOVANCT07260669
A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
A Phase 2 study testing Vipoglanstat in people with Endometriosis, run by Gesynta Pharma AB at 44 sites in 7 countries.
Trial summary
The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP). Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Vipoglanstat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 44 sitesin 7 countries
- Study dates
- 15 Oct 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
44 sites in 7 countries.
44 sites in 7 countries
Poland13 sites
Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O.
Bialystok, 15-224
Centrum Ginekologii Artemida
Bialystok, 15-464
In- Vivo Sp. z o. o.
Bydgoszcz, 85-048
NZOZ Medem
Katowice, 40-301
Centrum Medyczne Angelius Provita
Katowice, 40-611
NZOZ Vita Longa Sp. z o.o.
Katowice, 40-748
Medico Praktyka Lekarska
Krakow, 31315
Centrum Medyczne Chodzki
Lublin, 20-093
ETG Siedlce
Siedlce, 08-110
Aidport sp. Z o.o.
Skorzewo, 60-185
Twoja Przychodnia SCM
Szczecin, 71-500
Specjalistyczna Praktyka Lekarska Krzysztof Dynowski
Warsaw, 00-144
ETG JustMed
Warsaw, 01-691
United Kingdom10 sites
Accellacare Yorkshire
Bradford, BD18 3SA
Southmead Hospital - North Bristol NHS Trust
Bristol, BS10 5NB
Accellacare Northamptonshire
Corby, NN18 9EZ
Accellacare Warwickshire
Coventry, CV3 4FJ
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Accellacare North London
Northwood, HA6 2RN
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY
Accellacare South London
Orpington, BR5 3QG
University of Oxford
Oxford, OX3 9DU
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Czechia6 sites
Gynekologie MEDA s.r.o
Brno, 60200
Fakultni nemocnice Brno
Brno, 62500
NEUMED Gynekologicka Ambulance s.r.o.
Olomouc, 77900
Gyncare MUDr. Michael Svec s.r.o.
Pilsen, 32600
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
STELLA-GYN, s.r.o.
Vodňany, 38901
Romania6 sites
Genesys Fertility Center
Bucharest, 012071
Delta Health Care
Bucharest, 014142
Spitalul Clinic Filantropia
Bucharest
SC Centrul Medical Unirea SRL - Regina Maria
Iași, 700023
Spitalul Clinic Judetean de Urgenta Targu-Mures
Târgu Mureş, 540136
SC Centrul Medical Unirea SRL
Târgu Mureş, 540139
Hungary5 sites
MedEnd
Budapest, 1027
Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika
Budapest, 1082
Robert Karoly Private Hospital Tritonlife Medical Center
Budapest, 1134
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Somogy Varmegyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital)
Kaposvár, 7400
Bulgaria3 sites
MHAT Puls AD
Blagoevgrad, 2700
Lyulin Hospital
Sofia, 1336
FemiClinic
Sofia, 1700
About this study
Official 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
The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
- Conditions
- Endometriosis
- Being tested
- Vipoglanstat, Placebo
- Keywords
- Non-menstrual pelvic pain, Dysmenorrhea, Pelvic pain
- Medical subject headings
- Endometriosis, Dysmenorrhea, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VipoglanstatDrug
Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.
PlaceboDrug
Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Dose A Vipoglanstat | Experimental | Not described Receives: Drug: Vipoglanstat |
| Dose B Vipoglanstat | Experimental | Not described Receives: Drug: Vipoglanstat |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment
Measured: Baseline to 4 months
Secondary outcomes (8)
Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment
Measured: Baseline to 4 months
Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment
Measured: Baseline to 4 months
Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment
Measured: Baseline to 4 months
Change in Endometriosis Health Profile 30 Item Patient Reported Outcome (EHP-30) Score from Baseline to End of Treatment
Measured: Baseline to 4 months
Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment
Measured: Baseline to 4 months
Change in Mean Daily Opioid Rescue Medication Use for NMPP from Baseline to Fourth Month of Treatment
Measured: Baseline to 4 months
Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment
Measured: Baseline to 4 months
Number of Participants with Adverse Events
Any clinically significant changes in laboratory variables, including clinical chemistry, hematology, and urinalysis will be reported as adverse events.
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start15 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gesynta Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260669
- Sponsor's protocol ID
- GS-248-203
- Other IDs
- 2025-522452-16-00, 2025
- Acronym
- NOVA
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07260669
- Acronym / sponsor ID
- NOVA / GS-248-203
- Conditions
- Endometriosis
- Keywords
- Non-menstrual pelvic pain, Dysmenorrhea, Pelvic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Gesynta Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose A Vipoglanstat | Experimental | Drug: Vipoglanstat |
| Dose B Vipoglanstat | Experimental | Drug: Vipoglanstat |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VipoglanstatParticipants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period. | Drug | Dose A Vipoglanstat, Dose B Vipoglanstat |
| PlaceboParticipants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period. | Drug | Placebo |
Primary outcome
Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment
Time frame: Baseline to 4 months
8 secondary outcomes
Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment
Time frame: Baseline to 4 months
Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment
Time frame: Baseline to 4 months
Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment
Time frame: Baseline to 4 months
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
Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment
Time frame: Baseline to 4 months
Change in Mean Daily Opioid Rescue Medication Use for NMPP from Baseline to Fourth Month of Treatment
Time frame: Baseline to 4 months
Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment
Time frame: Baseline to 4 months
Number of Participants with Adverse Events
Time frame: Up to 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vipoglanstat in people with Endometriosis, run by Gesynta Pharma AB at 44 sites in 7 countries.
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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Poland, United Kingdom, Czechia, Romania, Hungary and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment (time frame: Baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.