NCT04428684

COMPARISON OF A NEW FORMULATION OF GOSERELIN (Pepti 3.6 mg) to Zoladex® 3.6 mg

COMPARISON OF A NEW FORMULATION OF GOSERELIN (Pepti 3.6 mg) to Zoladex® 3.6 mg IN PATIENTS WITH DYSFUNCTIONAL UTERINE BLEEDING REQUIRING ENDOMETRIAL ABLATION.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Peptigroupe Inc. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The comparator drug (Zoladex 3.6 mg) is approved for use as a thinning agent for the endometrium prior to endometrial ablation. The dosing recommendation is one or two depots with each depot given four weeks apart. When two depots are administered, surgery should be performed within two to four weeks following administration of the second depot.

Detailed description

The primary objective of the study is to demonstrate non-inferiority of a generic formulation of goserelin 3.6 mg as compared to Zoladex ® 3.6 mg on endometrial thinning prior to surgery. The study is an open label, multicenter, prospective, parallel group randomized study. Blind for Sponsor, ultrasound assessment, testing labs and statistician, the study will be performed in premenopausal women with dysfunctional uterine bleeding (DUB) eligible for endometrial ablation. Patients will be randomized in a 1 to 1 ratio to receive either the Peptigroupe test product (Pepti 3.6 mg) or Zoladex® 3.6 mg for a treatment of 8 weeks (two injections). Ultrasonic measurement of endometrial thickness will be performed on screening and on days 0 (pre-injection), 28 (pre-injection) and 42 (pre surgical procedure). The pharmacodynamics profile will be tabulated at the end of the study on the basis of the following data: 1. Estradiol 2. LH and FSH as additional information on hormone response Goserelin safety profile will be assessed throughout the study on the basis of the following assessments: 1. Treatment-emergent AEs 2. Physical examinations 3. Vital signs 4. 12-Lead ECG 5. Laboratory parameters (i.e., biochemistry, haematology, and urinalysis)

Conditions

• Dysfunctional Uterine Bleeding

Interventions

Type	Name	Description
DRUG	Pepti 3.6 mg	Each patient receives one injection of Pepti 3.6mg or Zoladex 3.6mg on Day 0 and a second injection of the same drug given the first time on Day 28. On Day 42 patients undergo endometrial ablation

Timeline

• Start date: 2018-10-29
• Primary completion: 2020-04-01
• Completion: 2020-06-07
• First posted: 2020-06-11
• Last updated: 2020-06-11

Locations

5 sites across 1 country: Ukraine