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Fertility PreservationPhase 2/3Erasme-POFNCT01160315

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

A Phase 2/3 study testing Triptorelin and Norethisterone acetate in people with Fertility Preservation and Alkylating Agents, run by Erasme University Hospital at 15 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Triptorelin and Norethisterone acetate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
15 sitesin 3 countries
Study dates
Jul 2002to Oct 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

Belgium7 sites

  • Algemeen Ziekenhuis Stuivenberg

    Antwerp, 2060

  • AZ St Jan

    Brugges, 8000

  • Bordet

    Brussels, 1000

  • Erasme Hospital

    Brussels, 1070

  • AZ-VUB

    Brussels, 1090

  • St Luc University

    Brussels, 1200

  • CHRU Lille

    Lille, 59037

Other trials in Belgium

France7 sites

  • CHU Dijon

    Dijon, 21034

  • CHU Nancy

    Nancy, 54511

  • Hôpital Hotel Dieu

    Paris, 75004

  • St Louis Hospital

    Paris, 75475

  • CHU St Antoine

    Paris, 75571

  • Henry-Mondor Hospital

    Paris-Creteil, 94010

  • Centre Henri Beckerel

    Rouen, 76038

Other trials in France

Italy1 site

  • Instituto Europeo di oncologia

    Milan, 1-20141

Other trials in Italy

About this study

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.

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.

Being tested
Triptorelin, Norethisterone acetate
Keywords
ovarian failure, chemotherapy, lymphoma, GnRH agonist
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TriptorelinDrug

    Also called Decapeptyl

    Triptorelin: intramusculAR injection every 3 months

  • Norethisterone acetateDrug

    Also called Primolut

    5 mg/day per os until during chemotherapy

Study groups in NCT01160315
Study groupRoleWhat they receive
Arm A (GnRha arm)ExperimentalIM injection of Triptorelin -Decapeptyl PR 11.25mg- (every 3 months) and Norethisterone acetate- Primolut-Nor 5 mg- per os continuously until the end of the chemotherapy
Receives: Drug: Triptorelin; Drug: Norethisterone acetate
Arm B (control Arm)Active comparatorNorethisterone acetate alone, 5mg par day, (ARM B) until the end of the chemotherapy.
Receives: Drug: Norethisterone acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Premature ovarian failure rate

    Primary endpoint is to evaluate the short and long-term efficacy of triptorelin depot plus progestin versus progestin alone to prevent POF induced by chemotherapy treatment. The ovarian function (FSH, E2, Progesterone, and AMH, presence of spontaneous menstrual cycle and pregnancies) will be evaluated every 3 months during the first 6 months after the end of chemotherapy, every 6 months during the next 18 months and once a year during an additional 5 years. All hormonal treatment has to be interrupted 10 days before the blood test.

    Measured: 5 years

Secondary outcomes (4)

  1. Impact of the flare-up effect of Triptorelin

    The Triptorelin/Norethisterone treatment has to start if possible 10 days before the beginning of the chemotherapy (time necessary to obtain the inhibitory effect of the Gn-Rha on the ovarian function)and at least the same day. The impact of the interval between the triptorelin/noresthisterone treatment and the start of the chemotherapy on the efficacy to protect ovarian function (FSH level at 2 years of follow-up) will be evaluated.

    Measured: 2 years

  2. Ovarian function during the treatment

    Evaluation of the inhibitory action of the treatment on ovarian function during the chemotherapy: the hormonal profile (FSH and estradiol levels) will be evaluated 10 days after the triptorelin/Norethisterone treatment start, before the second injection (3 months) and at the end of the chemotherapy. Adverse effects due to the injection are evaluated 7-10 days after each injection.

    Measured: 1 year

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

    Anamnesis including the compliance of the treatment (possible treatment interruption or dosage modification) and the adverse events are performed at each visit. All events expected and directly related to the chemotherapy or the initial pathology will be documented in the Case Report Form adverse events. Specific anamnesis concerning the possible adverse events due to treatment must be completed for each follow-up visit.

    Measured: 1 year

  4. Add back therapy effect

    Evaluation of the efficacy of concomitant administration of progestin alone as "Add Back Therapy" during the treatment: specific anamnesis including estrogen-deficiency symptoms (hot flushes, vaginal dryness...) is reported at each visit during the treatment. Osteodensitometry is performed after 1 year follow-up.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2010 (estimated)
  2. Study startJul 2002
  3. Primary completionJun 2010
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01160315
Sponsor's protocol ID
ErasmeUH
Acronym
Erasme-POF
Status last verified
Oct 2015
First submitted
7 Jul 2010
Last updated
30 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Demeestere I, Brice P, Peccatori FA, Kentos A, Gaillard I, Zachee P, Casasnovas RO, Van Den Neste E, Dechene J, De Maertelaer V, Bron D, Englert Y. Gonadotropin-releasing hormone agonist for the prevention of chemotherapy-induced ovarian failure in patients with lymphoma: 1-year follow-up of a prospective randomized trial. J Clin Oncol. 2013 Mar 1;31(7):903-9. doi: 10.1200/JCO.2012.42.8185. Epub 2012 Nov 5.

    PubMed 23129737

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Triptorelin and Norethisterone acetate in people with Fertility Preservation and Alkylating Agents, run by Erasme University Hospital at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Belgium, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Premature ovarian failure rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01160315, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.

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