PROtecting Ovaries and Fertility During Chemotherapy - The PROOF Trial

NCT00380406 | Completed Phase 3 DMC

• 1 other identifier: 2006603-01H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine whether gonadotropin releasing hormone agonists (medical therapy) will protect against ovarian failure in reproductive aged women undergoing sterilizing chemotherapy.

Conditions

Fertility Preservation; Cancer

Keywords

Gonadotropin releasing hormone agonist; GnRH; Fertility; Fertility preservation; Oncology; Cancer; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Protection against ovarian failure

  12 months post Chemo therapy

Secondary Outcomes (1)

• Sonographic (biophysical) and biochemical markers of ovarian reserve

  3,6,9,12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Leuprolide acetate

depot GnRHa (Leuprolide acetate (LA) 11.25 mg intramuscularly)

ACTIVE COMPARATOR

Drug: Leuprolide acetate

Interventions

Leuprolide acetate DRUG

Placebo; depot GnRHa (Leuprolide acetate (LA) 11.25 mg intramuscularly)

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women who are:
• between ages 18 to 38;
• who will be undergoing gonadotoxic (sterilizing) curative/ adjuvant chemotherapy for early stage disease; and
• have provided informed consent. All subjects will be enrolled from the Ottawa Hospital Regional Cancer Institute (OHRCC) and the Cancer Center of South Eastern Ontario at Kingston General Hospital (CCSEO).

You may not qualify if:

• Women who:
• have advanced stage disease and/or whose median survival is expected to be less than 6 months
• have cancer of the ovaries, uterus, or fallopian tubes;
• have clinical or biochemical evidence of diminished ovarian reserve (recent shortening of cycles \< 24 days between menses, age \> 38, elevated serum FSH (follicular stimulating hormone)\> 15 IU/L, or low antral follicle count (AFC- number of follicles less than 10 mm on day 2 or 3 of natural menses) on baseline pelvic ultrasound (\<5) or elevated day 2 or 3 estradiol (\> 280 pmol/ml);
• have previously received chemotherapy or abdominal/pelvic radiation or have planned to receive abdomino/pelvic radiation;
• are pregnant;
• have contraindications to intramuscular injections; or
• have a history of fractures secondary to/or documented osteoporosis.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• University of Ottawa: collaborator
• Queen's University: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Cancer Centre of Southeastern Ontario

Kingston, Ontario, K7L 5P9, Canada

Location

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Kingston General Hospital

Ottawa, Ontario, Canada

Location

Ottawa Hospital/OHRI

Ottawa, Ontario, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Leuprolide

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

• Sonya Kashyap, MD MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2006
• First Posted: September 26, 2006
• Study Start: January 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 5, 2017

Record last verified: 2010-08

Locations

CA (4)