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

Primary Purpose

Dysfunctional Uterine Bleeding

Status
Completed
Phase
Phase 1
Locations
Ukraine
Study Type
Interventional
Intervention
Pepti 3.6 mg
Sponsored by
Peptigroupe Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dysfunctional Uterine Bleeding

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1. 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.

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Exclusion Criteria:

  1. Be pregnant or have desire to conceive
  2. Have abnormal endometrial cytology as confirmed by histology
  3. Have active endometritis
  4. Have active pelvic inflammatory disease
  5. 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.
  6. Presence of bacteremia, sepsis, or other active systemic infection
  7. Have active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of inclusion
  8. Known/suspected gynecological malignancy within the past 5 years
  9. Known clotting defects or bleeding disorders
  10. Untreated/unevaluated cervical dysplasia
  11. Known/suspected abdominal/pelvic cancer
  12. Atypical Hyperplasia
  13. Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section
  14. Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
  15. Currently on anticoagulants
  16. 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
  17. Have a severe liver disease (e.g., cirrhosis, chronic active hepatitis or chronic persistent hepatitis) or has persistent ALT, AST ˃ 2 X ULN, serum creatinine ˃ 2 X ULN, serum bilirubin ˃ 2 X ULN
  18. Have received an investigational drug or participated in a clinical trial within the last 30 days
  19. Have clinically serious and/or unstable concurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
  20. Patients with BMI ˂ 18
  21. Anticoagulated patients with INR ≥ 2
  22. Patients with a history of QT prolongation, congenital long QT syndrome, electrolyte abnormalities, CHF, or concurrent administration with QT prolonging drugs or QTc ˃450 msec.

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Sites / Locations

  • Central Military Hospital
  • LLC Medical Center
  • Maternity Hospital no 3
  • Center for Innovative Medical Technologies of the National Academy of Sciences
  • City Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pepti 3.6 treatment

Zoladex 3.6 mg treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 9, 2020
Last Updated
June 9, 2020
Sponsor
Peptigroupe Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04428684
Brief Title
COMPARISON OF A NEW FORMULATION OF GOSERELIN (Pepti 3.6 mg) to Zoladex® 3.6 mg
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
June 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peptigroupe Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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: Estradiol 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: Treatment-emergent AEs Physical examinations Vital signs 12-Lead ECG Laboratory parameters (i.e., biochemistry, haematology, and urinalysis)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunctional Uterine Bleeding

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Comparative parallel design aimed at showing non-inferiority
Masking
Outcomes Assessor
Masking Description
Sponsor, independant statistician, radiologists and bioanalytical lab are all blinded to treatment regimen
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pepti 3.6 treatment
Arm Type
Experimental
Arm Description
Patients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28
Arm Title
Zoladex 3.6 mg treatment
Arm Type
Active Comparator
Arm Description
Patients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28
Intervention Type
Drug
Intervention Name(s)
Pepti 3.6 mg
Other Intervention Name(s)
Zoladex 3.6 mg
Intervention Description
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
Primary Outcome Measure Information:
Title
Non-inferiority in terms of activity of test drug versus comparator
Description
Non-inferiority of test drug compared to comparator in terms of reduction of the endometrial thickness prior to surgical ablation
Time Frame
1 year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. 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. - Exclusion Criteria: 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 Have active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of inclusion 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 Have a severe liver disease (e.g., cirrhosis, chronic active hepatitis or chronic persistent hepatitis) or has persistent ALT, AST ˃ 2 X ULN, serum creatinine ˃ 2 X ULN, serum bilirubin ˃ 2 X ULN Have received an investigational drug or participated in a clinical trial within the last 30 days Have clinically serious and/or unstable concurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy Patients with BMI ˂ 18 Anticoagulated patients with INR ≥ 2 Patients with a history of QT prolongation, congenital long QT syndrome, electrolyte abnormalities, CHF, or concurrent administration with QT prolonging drugs or QTc ˃450 msec. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonabes deRougé, MD
Organizational Affiliation
Peptigroupe Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrii Zaremba
Organizational Affiliation
Pharmaxi LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Central Military Hospital
City
Kyiv
ZIP/Postal Code
01133
Country
Ukraine
Facility Name
LLC Medical Center
City
Kyiv
ZIP/Postal Code
03039
Country
Ukraine
Facility Name
Maternity Hospital no 3
City
Kyiv
ZIP/Postal Code
03148
Country
Ukraine
Facility Name
Center for Innovative Medical Technologies of the National Academy of Sciences
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
City Clinical Hospital
City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD with other researchers

Learn more about this trial

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

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