Stopped: More critical projects were prioritized.
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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patient reported relief of menopausal symptoms
Timeframe: Baseline
Patient reported relief of menopausal symptoms
Timeframe: 1 month following injection
Patient reported relief of menopausal symptoms
Timeframe: 2 months following injection
Patient reported relief of menopausal symptoms
Timeframe: 3 months following injection
Patient reported sexual function
Timeframe: Baseline
Patient reported sexual function
Timeframe: 1 month following injection
Patient reported sexual function
Timeframe: 2 months following injection
Patient reported sexual function
Timeframe: 3 months following injection