Endometriosis PelvicPhase 2NCT07914062
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
A Phase 2 study testing Teverelix DP in people with Endometriosis Pelvic and Endometriosis Ovaries, run by Antev Ltd..
Trial summary
PRECISION-E2 is a Phase IIa randomized, placebo-controlled study evaluating the pharmacodynamic profile, safety and tolerability of teverelix in premenopausal women with moderate-to-severe pain associated with endometriosis in the United Arab Emirates. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Endometriosis Pelvic, Endometriosis Ovaries, Premenopausal
- What is being tested?
- Teverelix DP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Dec 2029
- 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 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female between the ages of 19 and 50 (premenopausal)
- Has given written consent
- Clinical diagnosis of endometriosis (laparoscopy or imaging) performed within 5 years of Screening
- The participant must have dysmenorrhea or pelvic pain associated with endometriosis, of which either one or both should be at least "moderate" as determined by the investigator or sub-investigator using the B\&B scale.
- The participant must have maximum VAS score > 30 for pelvic pain associated with endometriosis
- The participant has experienced a regular menstrual cycle (25 to 38 days) that should include menstrual bleeding of at least 3 consecutive days (at least 3 regular menstrual cycles to be confirmed)
Show all 12Show fewer
- Agrees to practice contraception, which does not include any form of hormonal contraception during the entire study period:
- Either by using double barrier contraception and in compliance with local guidelines,
- or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the patient
- Is not expected to undergo gynaecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the participant does not desire such treatment during this time frame.
- Agree to continue to use only the analgesic medication permitted by the protocol during the Treatment and Follow-up Periods
- For patients who already participate or are willing to participate in the Emirati Genome Program (EGP, willing to participate in the Pharmacogenomic Study
Who cannot join
- Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
- Subject has breast fed in the previous six months
- Subject has a history of previous non-response to Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary).
- Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
- Known clinically significant gynaecologic condition, PID, abnormal genital bleeding or uterine anomaly
- Bone mineral density by dual energy x-ray absorptiometry Z score of less than -2 at the lumbar spine, total hip or femoral neck
Show all 19Show fewer
- Subject has a history of osteoporosis or other metabolic bone disease
- BMI <17 or > 35
- Participated in another investigational study within 3 months before recruitment
- Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values:
- Liver function test (aspartate aminotransferase [ASAT/SGOT], alanine aminotransferase [ALAT/SGPT]), exceeding >2X the upper limit of the normal (ULN) range
- Total bilirubin exceeding >1.5X the upper limit of the normal (ULN) range
- An estimated glomerular filtration rate (eGFR) < 30 mL/min, based on creatinine clearance calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation normalised to an average surface area of 1.73m2, at the screening visit.
- Has congenital long QT syndrome or ECG abnormalities at screening
- Use of the following medications prior to and during study participation:
- Any other IMP (within 3 months of enrolment)
- Herbal medications known to have anti-androgenic effects
- Bethanechol chloride
- Any other medication or herbal product that may affect hormone levels and might, therefore, confound interpretation of the study results (e.g. St. John's wort) (within 3 months of enrolment)
About this study
Official title: PRECISION-E2 Study is a Prospective Genomic Guided Precision Medicine Phase IIa, Randomized, Placebo Controlled Clinical Study in Women With Moderate to Severe Pain Associated With Symptomatic Endometriosis in UAE.
PRECISION-E2 is a Phase IIa randomized, placebo-controlled study evaluating the pharmacodynamic profile, safety and tolerability of teverelix in premenopausal women with moderate-to-severe pain associated with endometriosis in the United Arab Emirates. The study will characterize the magnitude and duration of estradiol suppression following a single administration of teverelix and evaluate dose and route of administration, including subcutaneous and intramuscular administration, to inform subsequent clinical development.
The study also incorporates a prospective precision medicine component designed to explore associations between genomic variation and pharmacodynamic and clinical response to teverelix. In participants enrolled in the Emirati Genome Program, genomic data will be integrated with hormonal, pharmacokinetic and clinical outcomes to investigate potential biological determinants of treatment response.
Read the detailed description
PRECISION-E2 is designed as an early clinical development and precision medicine study to characterize the pharmacodynamic response to long-acting injectable teverelix in women with symptomatic endometriosis and to inform dose and route selection for subsequent development. Participants will be randomized to receive a single administration of teverelix by the subcutaneous or intramuscular route or placebo. Serial pharmacodynamic and pharmacokinetic assessments will characterize the onset, magnitude and duration of gonadotropin and estradiol suppression.
The study will evaluate whether teverelix can achieve sustained estradiol concentrations within a prespecified therapeutic range while characterizing safety, tolerability and preliminary changes in endometriosis-associated symptoms and patient-reported outcomes.
A prospective precision medicine component will leverage the genomic infrastructure available in the United Arab Emirates to explore biological determinants of interindividual variability in pharmacodynamic and clinical response. Where available and appropriately consented, genomic information will be integrated with pharmacokinetic, hormonal and clinical data to generate hypotheses for subsequent biomarker-informed development of teverelix.
Teverelix TFA is a long-acting gonadotropin-releasing hormone (GnRH) antagonist developed as an injectable sustained-release formulation. Sustained exposure is driven primarily by depot release, supporting evaluation of infrequent dosing strategies and alternative routes of administration and provides the rationale for investigating whether controlled estradiol suppression can be achieved and maintained within a range intended to balance therapeutic activity with the consequences of excessive estrogen suppression.This pharmacologic profile differentiates Teverelix from both daily oral GnRH antagonists and injectable GnRH agonists and supports evaluation in estrogen-dependent conditions such as endometriosis.
- Conditions
- Endometriosis Pelvic, Endometriosis Ovaries, Premenopausal, Endometriosis (Diagnosis), Dysmenorrhoea, Dyspareunia (Female)
- Being tested
- Teverelix DP, Teverelix DP Placebo
- Keywords
- Endometriosis, Infertility, Premenopausal, Teverelix, Precision Medicine, United Arab Emirates, Emirati Genome Program, Pharmacogenomics
- Medical subject headings
- Endometriosis, Disease, Dysmenorrhea, Dyspareunia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teverelix DPDrug
Single dose at Day 1 of 60 mg injection SC
Teverelix DPDrug
Single dose at Day 1 of 90 mg injection SC.
Teverelix DPDrug
Single dose at Day 1 of 90 mg injection IM
Teverelix DP PlaceboDrug
Single dose at Day 1 of placebo injection SC.
| Study group | Role | What they receive |
|---|---|---|
| Teverelix DP 60 mg SC | Active comparator | Not described Receives: Drug: Teverelix DP |
| Teverelix DP 90 mg SC | Active comparator | Not described Receives: Drug: Teverelix DP |
| Teverelix DP 90 mg IM | Active comparator | Not described Receives: Drug: Teverelix DP |
| Teverelix DP placebo SC | Placebo comparator | Not described Receives: Drug: Teverelix DP Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Serum Estradiol Maintained Within 20-50 pg/mL for at Least 14 Consecutive Days
Serum estradiol (E2) will be measured using a validated assay at the central laboratory at baseline, Days 1, 2, 8, 15, 22 and 29, and monthly through Day 197. A participant will be classed as a responder if E2 remains within 20-50 pg/mL inclusive (the estradiol therapeutic window described by Barbieri) for at least 14 consecutive days, as derived according to the Statistical Analysis Plan. The number and percentage of responders will be reported by treatment arm.
Measured: From Day 1 to Day 197
Secondary outcomes (14)
Maximum Observed Plasma Concentration (Cmax) of Teverelix
Cmax (ng/mL) derived by non-compartmental analysis of plasma teverelix concentrations, measured using a validated analytical method at a specialised laboratory, following a single SC or IM dose of Teverelix DP. Reported by treatment arm.
Measured: Day 1 (pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Time to Maximum Observed Plasma Concentration (Tmax) of Teverelix
Tmax (hours) derived by non-compartmental analysis of plasma teverelix concentrations, measured using a validated analytical method at a specialised laboratory, following a single SC or IM dose of Teverelix DP. Reported by treatment arm.
Measured: Day 1 (pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Teverelix
AUC0-t derived by non-compartmental analysis of plasma teverelix concentrations, measured using a validated analytical method at a specialised laboratory, following a single SC or IM dose of Teverelix DP. Reported by treatment arm.
Measured: Day 1 (pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Change From Baseline in Serum Estradiol Concentration
Serum estradiol (pg/mL) measured using a validated assay at the central laboratory. Baseline is the Day 1 pre-dose value. Reported by treatment arm.
Measured: Baseline (Day 1 pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Change From Baseline in Serum Luteinising Hormone (LH) Concentration
Serum LH (IU/L) measured using a validated assay at the central laboratory. Baseline is the Day 1 pre-dose value. Reported by treatment arm.
Measured: Baseline (Day 1 pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Change From Baseline in Serum Follicle-Stimulating Hormone (FSH) Concentration
Serum FSH (IU/L) measured using a validated assay at the central laboratory. Baseline is the Day 1 pre-dose value. Reported by treatment arm.
Measured: Baseline (Day 1 pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Duration of Serum Estradiol Within 20-50 pg/mL
Number of days from the first to the last consecutive serum estradiol value within 20-50 pg/mL during the treatment period, measured using a validated assay at the central laboratory and derived according to the Statistical Analysis Plan. Reported by treatment arm
Measured: Day 1 to Day 197
Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BAP)
Serum BAP concentrations (ng/mL) measured using a validated assay at the central laboratory. Percent change from baseline is calculated for each post-baseline visit, where baseline is the Day 1 pre-dose value. Reported by treatment arm.
Measured: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 113, 141, 169, 197, 281 and 365
Percent Change From Baseline in Urinary N-Telopeptide of Type I Collagen (NTx)
Urinary NTx (nmol BCE/mmol creatinine) measured using a validated assay at the central laboratory. Percent change from baseline is calculated for each post-baseline visit, where baseline is the Day 1 pre-dose value. Reported by treatment arm.
Measured: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 113, 141, 169, 197, 281 and 365
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse events will be coded using MedDRA and severity graded according to CTCAE v6.0. Reported by treatment arm.
Measured: Day 1 through Day 365
Number of Participants with Serious Adverse Events (SAEs)
Serious adverse events coded using MedDRA. Reported by treatment arm
Measured: Day 1 through Day 365
Number of Participants with Clinically Significant Abnormal Laboratory Values
Fasted haematology, biochemistry and coagulation tests and urinalysis, with abnormal values judged clinically significant by the investigator. Reported by treatment arm.
Measured: Baseline (Day 1 pre-dose) and Days 15, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Number of Participants with Clinically Significant 12-Lead ECG Abnormalities
Triplicate 12-lead ECGs, with findings judged clinically significant by the investigator. On Day 1, ECGs are recorded pre-dose and 2 hours post-dose. Reported by treatment arm.
Measured: Baseline (Day 1 pre-dose) and Days 15, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Change From Baseline in Dysmenorrhoea Score on the Biberoglu and Behrman (B&B) Scale
Dysmenorrhoea severity rated using the patient symptom component of the B\&B scale (0 = absent to 3 = severe); higher scores indicate more severe symptoms. Reported by treatment arm.
Measured: Baseline (Day 1) and Days 29, 57, 85, 113, 141, 169, 197, 281 and 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startFeb 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis PelvicStudies 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, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antev Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914062
- Sponsor's protocol ID
- ANT-3111-01
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECISION-E2 Study is a Prospective Genomic Guided Precision Medicine Phase IIa, Randomized, Placebo Controlled Clinical Study in Women With Moderate to Severe Pain Associated With Symptomatic Endometriosis in UAE.
- ClinicalTrials.gov ID
- NCT07914062
- Acronym / sponsor ID
- ANT-3111-01
- Conditions
- Endometriosis Pelvic, Endometriosis Ovaries, Premenopausal, Endometriosis (Diagnosis), Dysmenorrhoea, Dyspareunia (Female)
- Keywords
- Endometriosis, Infertility, Premenopausal, Teverelix, Precision Medicine, United Arab Emirates, Emirati Genome Program, Pharmacogenomics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Antev Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Nov 2026 (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.
PRECISION-E2 is a Phase IIa randomized, placebo-controlled study evaluating the pharmacodynamic profile, safety and tolerability of teverelix in premenopausal women with moderate-to-severe pain associated with endometriosis in the United Arab Emirates. The study will characterize the magnitude and duration of estradiol suppression following a single administration of teverelix and evaluate dose and route of administration, including subcutaneous and intramuscular administration, to inform subsequent clinical development.
The study also incorporates a prospective precision medicine component designed to explore associations between genomic variation and pharmacodynamic and clinical response to teverelix. In participants enrolled in the Emirati Genome Program, genomic data will be integrated with hormonal, pharmacokinetic and clinical outcomes to investigate potential biological determinants of treatment response.
Detailed description
PRECISION-E2 is designed as an early clinical development and precision medicine study to characterize the pharmacodynamic response to long-acting injectable teverelix in women with symptomatic endometriosis and to inform dose and route selection for subsequent development. Participants will be randomized to receive a single administration of teverelix by the subcutaneous or intramuscular route or placebo. Serial pharmacodynamic and pharmacokinetic assessments will characterize the onset, magnitude and duration of gonadotropin and estradiol suppression.
The study will evaluate whether teverelix can achieve sustained estradiol concentrations within a prespecified therapeutic range while characterizing safety, tolerability and preliminary changes in endometriosis-associated symptoms and patient-reported outcomes.
A prospective precision medicine component will leverage the genomic infrastructure available in the United Arab Emirates to explore biological determinants of interindividual variability in pharmacodynamic and clinical response. Where available and appropriately consented, genomic information will be integrated with pharmacokinetic, hormonal and clinical data to generate hypotheses for subsequent biomarker-informed development of teverelix.
Teverelix TFA is a long-acting gonadotropin-releasing hormone (GnRH) antagonist developed as an injectable sustained-release formulation. Sustained exposure is driven primarily by depot release, supporting evaluation of infrequent dosing strategies and alternative routes of administration and provides the rationale for investigating whether controlled estradiol suppression can be achieved and maintained within a range intended to balance therapeutic activity with the consequences of excessive estrogen suppression.This pharmacologic profile differentiates Teverelix from both daily oral GnRH antagonists and injectable GnRH agonists and supports evaluation in estrogen-dependent conditions such as endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Teverelix DP 60 mg SC | Active comparator | Drug: Teverelix DP |
| Teverelix DP 90 mg SC | Active comparator | Drug: Teverelix DP |
| Teverelix DP 90 mg IM | Active comparator | Drug: Teverelix DP |
| Teverelix DP placebo SC | Placebo comparator | Drug: Teverelix DP Placebo |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female between the ages of 19 and 50 (premenopausal)
- Has given written consent
- Clinical diagnosis of endometriosis (laparoscopy or imaging) performed within 5 years of Screening
- The participant must have dysmenorrhea or pelvic pain associated with endometriosis, of which either one or both should be at least "moderate" as determined by the investigator or sub-investigator using the B\&B scale.
- The participant must have maximum VAS score > 30 for pelvic pain associated with endometriosis
Key exclusion criteria (19 listed)
- Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
- Subject has breast fed in the previous six months
- Subject has a history of previous non-response to Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary).
- Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
- Known clinically significant gynaecologic condition, PID, abnormal genital bleeding or uterine anomaly
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 |
|---|---|---|
| Teverelix DPSingle dose at Day 1 of 60 mg injection SC | Drug | Teverelix DP 60 mg SC |
| Teverelix DPSingle dose at Day 1 of 90 mg injection SC. | Drug | Teverelix DP 90 mg SC |
| Teverelix DPSingle dose at Day 1 of 90 mg injection IM | Drug | Teverelix DP 90 mg IM |
| Teverelix DP PlaceboSingle dose at Day 1 of placebo injection SC. | Drug | Teverelix DP placebo SC |
Primary outcome
Percentage of Participants With Serum Estradiol Maintained Within 20-50 pg/mL for at Least 14 Consecutive Days
Time frame: From Day 1 to Day 197
Serum estradiol (E2) will be measured using a validated assay at the central laboratory at baseline, Days 1, 2, 8, 15, 22 and 29, and monthly through Day 197. A participant will be classed as a responder if E2 remains within 20-50 pg/mL inclusive (the estradiol therapeutic window described by Barbieri) for at least 14 consecutive days, as derived according to the Statistical Analysis Plan. The number and percentage of responders will be reported by treatment arm.
14 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Teverelix
Time frame: Day 1 (pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Time to Maximum Observed Plasma Concentration (Tmax) of Teverelix
Time frame: Day 1 (pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Teverelix
Time frame: Day 1 (pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Change From Baseline in Serum Estradiol Concentration
Time frame: Baseline (Day 1 pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Change From Baseline in Serum Luteinising Hormone (LH) Concentration
Time frame: Baseline (Day 1 pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Change From Baseline in Serum Follicle-Stimulating Hormone (FSH) Concentration
Time frame: Baseline (Day 1 pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Duration of Serum Estradiol Within 20-50 pg/mL
Time frame: Day 1 to Day 197
Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BAP)
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 113, 141, 169, 197, 281 and 365
Percent Change From Baseline in Urinary N-Telopeptide of Type I Collagen (NTx)
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 113, 141, 169, 197, 281 and 365
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 365
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 365
Number of Participants with Clinically Significant Abnormal Laboratory Values
Time frame: Baseline (Day 1 pre-dose) and Days 15, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Number of Participants with Clinically Significant 12-Lead ECG Abnormalities
Time frame: Baseline (Day 1 pre-dose) and Days 15, 29, 57, 85, 113, 141, 169, 197, 281 and 365
Change From Baseline in Dysmenorrhoea Score on the Biberoglu and Behrman (B&B) Scale
Time frame: Baseline (Day 1) and Days 29, 57, 85, 113, 141, 169, 197, 281 and 365
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 3 Nov 2026.
Related trials for Endometriosis Pelvic
Recruiting
Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Endometriosis (Diagnosis)
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
RecruitingObservational study
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Endometriosis
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
Active, not recruitingPhase 2
A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
Endometriosis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teverelix DP in people with Endometriosis Pelvic and Endometriosis Ovaries, run by Antev Ltd..
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 12 inclusion and 19 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 With Serum Estradiol Maintained Within 20-50 pg/mL for at Least 14 Consecutive Days (time frame: From Day 1 to Day 197). 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 3 Nov 2026.