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

NCT04428684 | Completed Phase 1

• 1 other identifier: Pepti 3.6 E 01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Dysfunctional Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• Non-inferiority in terms of activity of test drug versus comparator

  Non-inferiority of test drug compared to comparator in terms of reduction of the endometrial thickness prior to surgical ablation

  1 year

Study Arms (2)

Pepti 3.6 treatment

EXPERIMENTAL

Patients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28

Drug: Pepti 3.6 mg

Zoladex 3.6 mg treatment

ACTIVE COMPARATOR

Patients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28

Drug: Pepti 3.6 mg

Interventions

Pepti 3.6 mg DRUG

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

Also known as: Zoladex 3.6 mg

Pepti 3.6 treatment; Zoladex 3.6 mg treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Be pre-Menopausal females with regular menstrual cycles and \> 30 years of age 2. Premenopausal at enrollment as determined by FSH measurement ≤ 60 IU/mL. 3. Endometrial thickness at pre-treatment less than 20 mm. 4. Diagnosis of Dysfunctional Uterine Bleeding and requiring endometrial ablation 5. Tumour negative cytology and histology 6. Appropriate sized uterus with no anatomic pathologies 7. Patient is not pregnant and does not wish to become pregnant in the future 8. Patient is willing to use a non-hormonal contraception method during the study, nor an intra-uterine device 9. Patient has no endocrine disorders, is not receiving hormonal therapies or non-steroidal anti-inflammatory medication. (prophylactic antibiotics can be administered according to the usual practice of the investigator) 10. Have the ability to understand the requirements of the study and is willing to provide written informed consent 11. Agree to abide by the study restrictions and return for the required assessments 12. Only patients which can be discontinued safely from contra-indicated medications discussed below in section 7.4 can be included in the study.

You may not qualify if:

• Be pregnant or have desire to conceive
• Have abnormal endometrial cytology as confirmed by histology
• Have active endometritis
• Have active pelvic inflammatory disease
• Have active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Patient may be considered for study enrollment.
• Presence of bacteremia, sepsis, or other active systemic infection
• Known/suspected gynecological malignancy within the past 5 years
• Known clotting defects or bleeding disorders
• Untreated/unevaluated cervical dysplasia
• Known/suspected abdominal/pelvic cancer
• Atypical Hyperplasia
• Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section
• Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
• Currently on anticoagulants
• Have a known hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonists, any LHRH agonists (e.g., leuprolide (Lupron®), goserelin ( Zoladex®) etc.) or to the PLGA polymers contained in the study formulation

Sponsors & Collaborators

• Peptigroupe Inc.: lead

Study Sites (5)

Central Military Hospital

Kyiv, 01133, Ukraine

Location

LLC Medical Center

Kyiv, 03039, Ukraine

Location

Maternity Hospital no 3

Kyiv, 03148, Ukraine

Location

Center for Innovative Medical Technologies of the National Academy of Sciences

Kyiv, 04053, Ukraine

Location

City Clinical Hospital

Kyiv, 04112, Ukraine

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Bonabes deRougé, MD

  Peptigroupe Inc.

  STUDY DIRECTOR

• Andrii Zaremba

  Pharmaxi LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Sponsor, independant statistician, radiologists and bioanalytical lab are all blinded to treatment regimen
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparative parallel design aimed at showing non-inferiority

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: October 29, 2018
• Primary Completion: April 1, 2020
• Study Completion: June 7, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

UA (5)