Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids

NCT05568940 | Withdrawn

• 1 other identifier: 2023-9075
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tibolone; Add-back hormone replacement therapy; GnRH-agonist injection; menopausal hormone therapy; chemically-induced menopause

Outcome Measures

Primary Outcomes (8)

• Patient reported relief of menopausal symptoms

  Patient reported relief of menopausal symptoms will be evaluated using the Menopause rating scale (MRS). The MRS is a validated 11-item health-related quality of life scale (HRQoL), that measures the presence and severity of menopausal symptoms.

  Baseline

• Patient reported relief of menopausal symptoms

  Patient reported relief of menopausal symptoms will be evaluated using the Menopause rating scale (MRS). The MRS is a validated 11-item health-related quality of life scale (HRQoL), that measures the presence and severity of menopausal symptoms.

  1 month following injection

• Patient reported relief of menopausal symptoms

  Patient reported relief of menopausal symptoms will be evaluated using the Menopause rating scale (MRS). The MRS is a validated 11-item health-related quality of life scale (HRQoL), that measures the presence and severity of menopausal symptoms.

  2 months following injection

• Patient reported relief of menopausal symptoms

  Patient reported relief of menopausal symptoms will be evaluated using the Menopause rating scale (MRS). The MRS is a validated 11-item health-related quality of life scale (HRQoL), that measures the presence and severity of menopausal symptoms.

  3 months following injection

• Patient reported sexual function

  Patient reported relief of sexual dysfunction (a menopausal symptom) will be evaluated using the Abbreviated female sexual function index (AFSFI). The abbreviated FSFI is a validated 6-item self-report questionnaire designed to assess female sexual function, comprised of six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.

  Baseline

• Patient reported sexual function

  Patient reported relief of sexual dysfunction (a menopausal symptom) will be evaluated using the Abbreviated female sexual function index (AFSFI). The abbreviated FSFI is a validated 6-item self-report questionnaire designed to assess female sexual function, comprised of six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.

  1 month following injection

• Patient reported sexual function

  Patient reported relief of sexual dysfunction (a menopausal symptom) will be evaluated using the Abbreviated female sexual function index (AFSFI). The abbreviated FSFI is a validated 6-item self-report questionnaire designed to assess female sexual function, comprised of six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.

  2 months following injection

• Patient reported sexual function

  Patient reported relief of sexual dysfunction (a menopausal symptom) will be evaluated using the Abbreviated female sexual function index (AFSFI). The abbreviated FSFI is a validated 6-item self-report questionnaire designed to assess female sexual function, comprised of six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.

  3 months following injection

Secondary Outcomes (10)

• Control of endometriosis symptoms

  Baseline

• Control of endometriosis symptoms

  1 month following injection

• Control of endometriosis symptoms

  2 months following injection

• Control of endometriosis symptoms

  3 months following injection

• Tolerability of the regimen

  1 month following injection

Study Arms (1)

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.

Drug: Tibolone 2.5 Mg Oral Tablet

Interventions

Tibolone 2.5 Mg Oral Tablet DRUG

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).

Also known as: Livial

Pre-menopausal women >18 years old with endometriosis and/or uterine fibroids

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pre-menopausal women over 18 years of age with known or suspected endometriosis and/or uterine fibroids who will undergo medical management of endometriosis with a depot injection of GnRH-a for 3 months

You may qualify if:

• 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

You may not qualify if:

• 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)
• Prior hysterectomy
• Menopausal status
• Pregnant or seeking pregnancy

Sponsors & Collaborators

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

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Endometriosis; Leiomyoma

Interventions

tibolone; Tablets

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Andrew Zakhari, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 6, 2022
• Study Start: September 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)