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Dysfunctional Uterine BleedingPhase 1NCT04428684

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

A Phase 1 study testing Pepti 3.6 mg in people with Dysfunctional Uterine Bleeding, run by Peptigroupe Inc. at 5 sites in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Dysfunctional Uterine Bleeding
What is being tested?
Pepti 3.6 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
5 sitesUkraine
Study dates
29 Oct 2018to 7 Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • -

Who cannot join

  • 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
Show all 23Show fewer
  • 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.
  • -

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Ukraine5 sites

  • Central Military Hospital

    Kyiv, 01133

  • LLC Medical Center

    Kyiv, 03039

  • Maternity Hospital no 3

    Kyiv, 03148

  • Center for Innovative Medical Technologies of the National Academy of Sciences

    Kyiv, 04053

  • City Clinical Hospital

    Kyiv, 04112

Other trials in Ukraine

About this study

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.

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.

Read the 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)
Being tested
Pepti 3.6 mg
Medical subject headings
Metrorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pepti 3.6 mgDrug

    Also called Zoladex 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

Study groups in NCT04428684
Study groupRoleWhat they receive
Pepti 3.6 treatmentExperimentalPatients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28
Receives: Drug: Pepti 3.6 mg
Zoladex 3.6 mg treatmentActive comparatorPatients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28
Receives: Drug: Pepti 3.6 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start29 Oct 2018
  3. Primary completion1 Apr 2020
  4. Study completion7 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparative parallel design aimed at showing non-inferiority
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04428684
Sponsor's protocol ID
Pepti 3.6 E 01
Status last verified
Jun 2020
First submitted
9 Jun 2020
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share IPD with other researchers

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pepti 3.6 mg in people with Dysfunctional Uterine Bleeding, run by Peptigroupe Inc. at 5 sites in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-inferiority in terms of activity of test drug versus comparator (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04428684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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