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Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids

NCT05568940 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-05-30

No results posted yet for this study

Summary

While there are many medical options for managing endometriosis and fibroids, GnRH-agonist (GnRH-a) therapy remains a very common method of treating these complex conditions. Although this therapy is effective, it does come with significant menopausal side effects, such as hot flashes, sweating, mood changes, sleep disturbance, altered sex drive, decreased bone density, and vaginal and urinary symptoms.

In short, chemically-induced menopause (menopause triggered by GnRH-a injection) causes the same symptoms of natural menopause, but with a sudden onset in a generally young and active population. Low dose hormone add-back therapy is commonly used to lessen these side effects of GnRH-a use.

There are many menopausal hormone therapies (MHTs) used in menopausal women that can help, but few studies have directly evaluated the different options of treatment for women undergoing chemically-induced menopause. Tibolone is a menopausal hormone therapy (MHT) that stands out as a good option in the management of medical menopause in endometriosis patients because it may give fewer side effects than other alternatives and have a positive effect on mood and libido.

This study aims to see how effective Tibolone is as an add-back therapy in women who are hormonally suppressed with a GnRH-a. For this study, we will recruit pre-menopausal women over the age of 18 years old undergoing therapy with the GnRH-a Lupron.

Conditions

  • Endometriosis
  • Fibroids

Interventions

DRUG

Tibolone 2.5 Mg Oral Tablet

Tibolone oral therapy for 2-3 months: All participants will take a Tibolone 2.5 mg tablet orally daily, at the same time each day, following a scheduled, luteal-phase injection of leuprolide acetate 11.25mg intramuscular (IM).

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Andrew Zakhari, M.D. · McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05568940 on ClinicalTrials.gov