Ovarian Function Clinical Trial
Official title:
Use of the GnRH Agonist Leuprolide Acetate (Lupron(Registered Trademark)) to Preserve Ovarian Function in Women Undergoing Chemotherapy
Verified date | July 22, 2010 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 22, 2010 |
Est. primary completion date | July 22, 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 10 Years to 21 Years |
Eligibility |
- INCLUSION CRITERIA: 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). EXCLUSION CRITERIA: 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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. Erratum in: Lancet. 2004 Dec 4;364(9450):2020. — View Citation
Oktay KH, Yih M. Preliminary experience with orthotopic and heterotopic transplantation of ovarian cortical strips. Semin Reprod Med. 2002 Feb;20(1):63-74. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antimullerian hormone, ovarian follicle count | 2-years | ||
Secondary | Menstrual history | 2-years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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|
N/A | |
Withdrawn |
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