GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients

NCT00429494 | Completed Phase 2 Results

• 1 other identifier: ID01-710
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

• To determine the effectiveness of the 3-month depot leuprolide in inducing and maintaining secondary amenorrhea in patients undergo hematopoietic stem cell transplantation.
• To determine the incidence of regained ovarian function manifested as spontaneous restoration of menstruation and normalization of hormonal level in patients after transplantation and discontinuation of long-acting leuprolide.

Conditions

Amenorrhea; Premature Ovarian Failure; Ovarian Function Insufficiency

Keywords

Hematopoietic Stem Cell Transplantation; GnRH Analogue; Gonadotropin-releasing hormone analogue; GnRH-a; Ovarian Function; Fertility; Leuprolide Acetate; Lupron Depot; premature ovarian failure; POF; Abnormal suppression of menstruation; absence of menstruation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide

  Hormonal profile blood tests including follicle-stimulating hormone (FSH) test, luteinizing hormone (LH) and estradiol levels done every two months with menstruation questionnaire, starting three months after the injection of the second dose of leuprolide until the restoration of spontaneous menstruation or the presence of ovarian failure. Any unexpected vaginal bleeding or side effects during the period covered by leuprolide injection, which is 6 months, is recorded by participants in a monitoring checklist sheet given to them.

  6 months

Study Arms (1)

Leuprolide Acetate

EXPERIMENTAL

Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.

Drug: Leuprolide Acetate; Behavioral: Questionnaire; Procedure: Hematopoietic Stem Cell Transplantation

Interventions

Leuprolide Acetate DRUG

22.5 mg IM injection 2 months before transplant and 3 months post-transplant.

Also known as: Leuprolide Acetate (delayed release), Lupron Depot

Leuprolide Acetate

Questionnaire BEHAVIORAL

Questionnaires taking about 15 minutes to complete.

Also known as: Survey

Leuprolide Acetate

Hematopoietic Stem Cell Transplantation PROCEDURE

Stem cell infusion on Day 0.

Also known as: HSCT, Stem Cell Transplant

Leuprolide Acetate

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Hematopoietic stem cell transplantation candidate.
• Post-menarche female less than 40 years old.
• Premenopausal before the start of transplantation, or the start of oral contraceptive pills.
• Follicle-stimulating hormone (FSH) less than or equal to 20 IU/L and Luteinizing hormone (LH) less than or equal to 20 IU/L within 1 weeks of initiation of injection or the ovarian status is determined by Gynecology Oncology Service.
• Agree to stop any oral contraceptive pills for a period of 3-6 months starting 1 year post-transplant

You may not qualify if:

• Breast cancer
• Ovarian cancer
• Pregnancy
• Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• TAP Pharmaceutical Products Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Cheng YC, Takagi M, Milbourne A, Champlin RE, Ueno NT. Phase II study of gonadotropin-releasing hormone analog for ovarian function preservation in hematopoietic stem cell transplantation patients. Oncologist. 2012;17(2):233-8. doi: 10.1634/theoncologist.2011-0205. Epub 2012 Jan 26.

  PMID: 22282904 RESULT

Related Links

• The University of Texas (UT) MD Anderson Cancer Center official website

MeSH Terms

Conditions

Amenorrhea; Primary Ovarian Insufficiency

Interventions

Leuprolide; Surveys and Questionnaires; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

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; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Naoto T. Ueno, MD, PhD / Professor
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Naoto Ueno, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 31, 2007
• Study Start: November 1, 2002
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 9, 2013
• Results First Posted: July 9, 2013

Record last verified: 2013-05

Locations

US (1)