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NOT YET RECRUITING
NCT07914062
PHASE2

PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates

Sponsor: Antev Ltd.

View on ClinicalTrials.gov

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. 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.

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.

Key Details

Gender

FEMALE

Age Range

19 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2027-02

Completion Date

2029-12

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Teverelix DP

Single dose at Day 1 of 60 mg injection SC

DRUG

Teverelix DP

Single dose at Day 1 of 90 mg injection SC.

DRUG

Teverelix DP

Single dose at Day 1 of 90 mg injection IM

DRUG

Teverelix DP Placebo

Single dose at Day 1 of placebo injection SC.