Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Key facts
- Who runs it
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- Sept 2024
- Ended
- Apr 2026
- Type of study
- Observational
- Treatments tested
- Tibolone 2.5 Mg Oral Tablet
- Record updated
- 30 May 2024
- Why it stopped
- More critical projects were prioritized.
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- Pre-menopausal woman over 18 years of age with known or suspected endometriosis and/or uterine fibroids
- Undergoing medical management of endometriosis with a depot injection of GnRH-a for 3 months
- Off all other hormonal medications for the period of this treatment
- With or without history of recent hormonal treatment for endometriosis
- Able to provide informed consent
Who cannot take part
- Prior hysterectomy
- Allergy or contraindication to GnRH-a therapy, tibolone, or any contraindications to estrogen or progestin replacement
- Any uncontrolled endocrinopathy (ex: Pituitary gland disorder, uncontrolled hypothyroidism, etc)
- Menopausal status
- Pregnant or seeking pregnancy
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Pre-menopausal women >18 years old with endometriosis and/or uterine fibroids
GnRH-a depot (11.25mg IM x 1) and daily Tibolone 2.5mg orally once a day for 2-3 months.
Treatment: Tibolone 2.5 Mg Oral Tablet
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 30 May 2024