A Phase 2 interventional study of Teverelix DP and Teverelix DP in Endometriosis Pelvic, Endometriosis Ovaries and Premenopausal, sponsored by Antev Ltd.. Not yet recruiting. Open to female participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Antev Ltd. · Phase 2, Interventional, and Treatment
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.
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.
929 studies on the registry are indexed under Endometriosis; 267 are open to participants now.
This study's planned enrollment of 84 is above the median of 66 across 541 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Antev Ltd. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Agrees to practice contraception, which does not include any form of hormonal contraception during the entire study period:
Exclusion Criteria:
Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values:
Use of the following medications prior to and during study participation:
Drug: Teverelix DP
Drug: Teverelix DP
Drug: Teverelix DP
Drug: Teverelix DP Placebo
Single dose at Day 1 of 60 mg injection SC
Single dose at Day 1 of 90 mg injection SC.
Single dose at Day 1 of 90 mg injection IM
Single dose at Day 1 of placebo injection SC.
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.
Time frame: From Day 1 to Day 197
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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
Time frame: 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.
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)
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.
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)
Adverse events will be coded using MedDRA and severity graded according to CTCAE v6.0. Reported by treatment arm.
Time frame: Day 1 through Day 365
Number of Participants with Serious Adverse Events (SAEs)
Serious adverse events coded using MedDRA. Reported by treatment arm
Time frame: 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.
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
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.
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
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.
Time frame: Baseline (Day 1) and Days 29, 57, 85, 113, 141, 169, 197, 281 and 365
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Antev Ltd.