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Efficiency of Gonadotropin-releasing Hormone (GnRH) Agonist in Preventing Chemotherapy Induced Ovarian Failure

Information source: Erasme University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Function Restoration After Chemotherapy for Lymphoma

Intervention: GnRH agonist (triptorelin)+ Norethisterone acetate (Drug); Norethisterone acetate (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Erasme University Hospital

Official(s) and/or principal investigator(s):
Yvon Englert, MD, PhD, Study Director, Affiliation: Erasme Hospital

Summary

Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to treat neoplastic and benign diseases. These drugs are definitely associated with premature ovarian failure (POF), resulting in an important decrease of the long-term quality of life and an increase of morbidity. A recent study showed that the patients treated by alkylating agents had a 4. 52 fold higher risk to lose their ovarian function compared with those who were treated by other agents. The rate of POF after treatment ranged from 40 to 80%, according to the age of the patients and the total doses administered. Young women who experience POF have to face with the prospects of infertility and to consider years of hormonal replacement therapy. The possibility of minimizing gonadal damage by administering of protective therapy during chemotherapy represents an attractive option for these patients. The aim of this study is to evaluate the protective effect on the ovarian function of the gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data in human are, however, highly controversial.

Clinical Details

Official title: A Prospective Open Randomized Trial on the Efficacy of Gonadotropin-releasing Hormone Agonist Depot-Triptorelin- to Prevent Chemotherapy Induced Premature Ovarian Failure in Lymphoma Patients.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Premature ovarian failure rate

Secondary outcome:

Impact of the flare-up effect of Triptorelin

Ovarian function during the treatment

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Add back therapy effect

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women between 18 and 45 years old with lymphoma.

- Menarche >2year

- Subject treated by chemotherapy-induced ovarian failure including alkylant agents

(except less than 8 ABVD)

- Presence of both ovaries (ovarian biopsy or hemiovariectomy for cryopreservation

before treatment is accepted).

- Ability to give written informed consent

Exclusion Criteria:

- Hormonal-sensible malignancy

- Chemotherapy or radiotherapy before the inclusion in the study

- Pelvic irradiation including the ovaries or TBI

- Pregnancy

- Patient weight above 110 kg

- Anamnesis of thrombo-embolic processes

- Severe hepatic or renal insufficiency

- Systolic blood pressure >15mmHg or diastolic blood pressure > 90mmHg

- Contraindication of IM injection

- Relevant ovarian abnormalities (Functional follicular cyst are tolerated)

- Anamnesis of premature ovarian failure or irregular cycle (repeated amenorrhoea >2

months)

- Dubin-Johnson and Rotor Syndrome

Locations and Contacts

Algemeen Ziekenhuis Stuivenberg, Antwerpen 2060, Belgium

AZ St Jan, Brugges 8000, Belgium

AZ-VUB, Brussels 1090, Belgium

Bordet, Brussels 1000, Belgium

Erasme Hospital, Brussels 1070, Belgium

St Luc University, Brussels 1200, Belgium

CHRU Lille, Lille 59037, Belgium

CHU Dijon, Dijon 21034, France

CHU Nancy, Nancy 54511, France

Henry-Mondor Hospital, Paris-Creteil 94010, France

CHU St Antoine, Paris 75571, France

Hôpital Hotel Dieu, Paris 75004, France

St Louis Hospital, Paris 75475, France

Centre Henri Beckerel, Rouen 76038, France

Instituto Europeo di oncologia, Milano 1-20141, Italy

Additional Information

Starting date: July 2002
Last updated: July 30, 2010

Page last updated: August 23, 2015

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