Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy

NCT00507780 | Withdrawn Phase 4

• 2 other identifiers: 07019307-CH-0193
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether the drug cetrorelex acetate (Cetrotide\[Registed Trademark\]) can protect ovarian function in women undergoing chemotherapy. Some cancer treatments are known to cause a change in women's periods or to cause menstruation to stop completely, so that they cannot become pregnant. Cetrorelex acetate has been used for many years to lower hormone levels and stop periods in patients undergoing in vitro fertilization treatments. This study will see if making the ovaries inactive may protect them from being affected by certain cancer drugs, and thus preserve fertility. Women up to age 21who have begun menstruating, who have their uterus and at least one functioning ovary, and who are undergoing chemotherapy with cyclophosphamide, busulfan, nitrogen mustard or L-phenalanin mustard may be eligible for this study. Participants undergo the following procedures during this 24-month study: Baseline evaluation

• Medical history, physical examination and blood and urine tests
• Questionnaire about quality of life, menstrual periods, vaginal bleeding and desire for future fertility
• 3D ultrasound of abdomen
• DEXA scan to evaluate bone density Assignment to treatment with:
• Lo ovral (contraceptive pill to prevent pregnancy and control menstrual periods) alone, or
• Lo ovral and the study drug cetrorelex acetate, given as an injection under the skin once a day for six menstrual cycles Evaluations
• Transvaginal 3D ultrasound to monitor changes in the ovary - after 6 months of cetrorelex acetate injections
• DEXA scan - after 6 months of cetrorelex acetate injections
• Blood tests for safety monitoring, pregnancy testing, endocrine tests and research uses - every 3 months during first year, every 6 months during second year
• Questionnaire to monitor changes and quality of life - every 3 months during first year, every 6 months during second year.

Conditions

Ovarian Function; Preservation of Ovarian Function

Keywords

GnRH Antagonist; Premature Ovarian Failure; Fertility; Chemotherapy; POF

Outcome Measures

Primary Outcomes (1)

• Antimullerian hormone, ovarian follicle count

  2-years

Secondary Outcomes (1)

• Menstrual history

  2-years

Interventions

GnRH antagonist DRUG

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All reproductive age women menarche - age 21, undergoing chemotherapy with agents known to affect ovarian function that have a follicle stimulating hormone level (FSH) less than 20 mIU/L will be offered enrollment. We define premature ovarian failure as the development before age 40 years of greater than 4 months of amenorrhea or menstrual irregularity, associated with two serum FSH levels in the menopausal range (sampled at least 1 mo apart).

You may not qualify if:

• FSH greater than 20 mIU/L
• Sensitivity or allergy to oral contraceptives (lo ovral) or cetrorelix acetate
• Patients who have had surgical removal of their ovaries
• Patients who are currently pregnant or attempting conception
• Severe renal impairment
• Premenarchal patients
• Patients greater than 21
• Patients who have undergone radiation therapy or who are scheduled to undergo radiation therapy during the study period.
• Patients with a family history of premature ovarian failure

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Oktay KH, Yih M. Preliminary experience with orthotopic and heterotopic transplantation of ovarian cortical strips. Semin Reprod Med. 2002 Feb;20(1):63-74. doi: 10.1055/s-2002-23520.

  PMID: 11941536 BACKGROUND

• Donnez J, Dolmans MM, Demylle D, Jadoul P, Pirard C, Squifflet J, Martinez-Madrid B, van Langendonckt A. Livebirth after orthotopic transplantation of cryopreserved ovarian tissue. Lancet. 2004 Oct 16-22;364(9443):1405-10. doi: 10.1016/S0140-6736(04)17222-X.

  PMID: 15488215 BACKGROUND

• Teinturier C, Hartmann O, Valteau-Couanet D, Benhamou E, Bougneres PF. Ovarian function after autologous bone marrow transplantation in childhood: high-dose busulfan is a major cause of ovarian failure. Bone Marrow Transplant. 1998 Nov;22(10):989-94. doi: 10.1038/sj.bmt.1701483.

  PMID: 9849696 BACKGROUND

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: July 18, 2007
• Primary Completion: July 22, 2010
• Study Completion: July 22, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-07-22

Locations

US (1)