EndometriosiseTAPENCT05568940
Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
An observational study of Endometriosis and Fibroids, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Fibroids
- What is being tested?
- Tibolone 2.5 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2024to Apr 2026
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Endometriosis is a common condition affecting approximately one in ten women, with significant adverse effects on women's quality of life and reproductive health. While there are numerous medical options for managing pain symptoms and reducing lesion size, GnRH-a therapy remains a mainstay of treating this complex condition. Similarly, uterine fibroids can cause heavy bleeding with associated anemia, and bulk symptoms, which may require surgical management. These hormone-sensitive fibroids regress and bleeding subsides when treatment with GnRH-a is used. This generally young and otherwise healthy population undergoes suppression of the hypothalamic-pituitary-ovarian axis in order to manage symptoms of either endometriosis or fibroids, or both if present concomitantly.
The efficacy of GnRH-a therapy has been extensively demonstrated in the literature albeit at the cost of significant menopausal side effects such as vasomotor symptoms, mood changes, sleep disturbance, altered libido, decreased bone mineral density, and genitourinary symptoms. In short, chemically-induced menopause confers the validated symptoms of natural menopause, but with an abrupt onset in a generally young and active population.
Add-back therapy with low-dose hormonal preparations is commonly used to mitigate the unwanted but largely inevitable adverse effects of GnRH-a use. Theoretically, any menopausal hormone therapy (MHT) used in menopausal women could serve the purpose, however few studies have evaluated directly the differing options in this unique population. One MHT preparation that stands out as a valuable option in the management of medical menopause in endometriosis patients is Tibolone. Tibolone is a synthetic steroid prodrug with active metabolites that exhibit estrogenic, progestogenic, and androgenic activity.
Prior studies have demonstrated that add-back treatment with Tibolone significantly reduces bone mineral density loss and vasomotor symptoms that normally occur with GnRH-a treatment. In addition, Tibolone has been shown to cause significantly fewer bleeding and spotting episodes and less breast tenderness than combined hormone replacement therapy (HRT) preparations, and has also been shown to improve mood and libido in menopausal women, making it a unique and attractive option in younger women undergoing temporary, chemical menopause.
This is a prospective open-label observational cohort study. Pre-menopausal women over 18 years of age with known or suspected endometriosis or uterine fibroids who will be undergoing treatment with an injectable GnRH-agonist (leuprolide acetate) at the Royal Victoria Hospital (Glen site) will be recruited and screened for exclusion criteria. Consenting participants of the study will receive a phone call before their GnRH-a treatment to report menopausal symptoms and endometriosis symptoms in a baseline evaluation. After their GnRH-a treatment, participants will be contacted, by phone call, one, two and three months post treatment to be asked a standardized set of questions to evaluate relief of menopausal symptoms, control of endometriosis symptoms, as well as adherence to treatment, and side-effects. Add-back will commence one month after the initial injection of GnRH-a, such that the incidence of vasomotor symptoms and other side-effects of GnRH-a may be observed. In this way, this is a crossover study by design in which patients will serve as their own controls, before and after initiating add-back therapy with Tibolone. Participants will always reserve the right to commence Tibolone sooner than 1 month if they experience bothersome side-effects.
- Conditions
- Endometriosis, Fibroids
- Being tested
- Tibolone 2.5 Mg Oral Tablet
- Keywords
- Tibolone, Add-back hormone replacement therapy, GnRH-agonist injection, menopausal hormone therapy, chemically-induced menopause
- Medical subject headings
- Endometriosis, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibolone 2.5 Mg Oral TabletDrug
Also called Livial
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tibolone 2.5 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months following injection
Secondary outcomes (10)
Control of endometriosis symptoms
Control of endometriosis symptoms will be evaluated using a modified Biberoglu \& Behrman (B\&B) scale. This is a validated scale that evaluates endometriosis pain by patient's self-assessment of three pain symptoms (dysmenorrhea, dyspareunia, and chronic pelvic pain).
Measured: Baseline
Control of endometriosis symptoms
Control of endometriosis symptoms will be evaluated using a modified Biberoglu \& Behrman (B\&B) scale. This is a validated scale that evaluates endometriosis pain by patient's self-assessment of three pain symptoms (dysmenorrhea, dyspareunia, and chronic pelvic pain).
Measured: 1 month following injection
Control of endometriosis symptoms
Control of endometriosis symptoms will be evaluated using a modified Biberoglu \& Behrman (B\&B) scale. This is a validated scale that evaluates endometriosis pain by patient's self-assessment of three pain symptoms (dysmenorrhea, dyspareunia, and chronic pelvic pain).
Measured: 2 months following injection
Control of endometriosis symptoms
Control of endometriosis symptoms will be evaluated using a modified Biberoglu \& Behrman (B\&B) scale. This is a validated scale that evaluates endometriosis pain by patient's self-assessment of three pain symptoms (dysmenorrhea, dyspareunia, and chronic pelvic pain).
Measured: 3 months following injection
Tolerability of the regimen
This will be discussed during the monthly phone call with the participant.
Measured: 1 month following injection
Tolerability of the regimen
This will be discussed during the monthly phone call with the participant.
Measured: 2 months following injection
Tolerability of the regimen
This will be discussed during the monthly phone call with the participant.
Measured: 3 months following injection
Incidence of major side effects
This will be discussed during the monthly phone call with the participant.
Measured: 1 month following injection
Incidence of major side effects
This will be discussed during the monthly phone call with the participant.
Measured: 2 months following injection
Incidence of major side effects
This will be discussed during the monthly phone call with the participant.
Measured: 3 months following injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study startSep 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Why it stopped: More critical projects were prioritized.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Zakhari, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Andrew Zakhari, M.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568940
- Sponsor's protocol ID
- 2023-9075
- Acronym
- eTAPE
- Status last verified
- May 2024
- First submitted
- 25 Sep 2022
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
- ClinicalTrials.gov ID
- NCT05568940
- Acronym / sponsor ID
- eTAPE / 2023-9075
- Conditions
- Endometriosis, Fibroids
- Keywords
- Tibolone, Add-back hormone replacement therapy, GnRH-agonist injection, menopausal hormone therapy, chemically-induced menopause
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: More critical projects were prioritized.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Endometriosis is a common condition affecting approximately one in ten women, with significant adverse effects on women's quality of life and reproductive health. While there are numerous medical options for managing pain symptoms and reducing lesion size, GnRH-a therapy remains a mainstay of treating this complex condition. Similarly, uterine fibroids can cause heavy bleeding with associated anemia, and bulk symptoms, which may require surgical management. These hormone-sensitive fibroids regress and bleeding subsides when treatment with GnRH-a is used. This generally young and otherwise healthy population undergoes suppression of the hypothalamic-pituitary-ovarian axis in order to manage symptoms of either endometriosis or fibroids, or both if present concomitantly.
The efficacy of GnRH-a therapy has been extensively demonstrated in the literature albeit at the cost of significant menopausal side effects such as vasomotor symptoms, mood changes, sleep disturbance, altered libido, decreased bone mineral density, and genitourinary symptoms. In short, chemically-induced menopause confers the validated symptoms of natural menopause, but with an abrupt onset in a generally young and active population.
Add-back therapy with low-dose hormonal preparations is commonly used to mitigate the unwanted but largely inevitable adverse effects of GnRH-a use. Theoretically, any menopausal hormone therapy (MHT) used in menopausal women could serve the purpose, however few studies have evaluated directly the differing options in this unique population. One MHT preparation that stands out as a valuable option in the management of medical menopause in endometriosis patients is Tibolone. Tibolone is a synthetic steroid prodrug with active metabolites that exhibit estrogenic, progestogenic, and androgenic activity.
Prior studies have demonstrated that add-back treatment with Tibolone significantly reduces bone mineral density loss and vasomotor symptoms that normally occur with GnRH-a treatment. In addition, Tibolone has been shown to cause significantly fewer bleeding and spotting episodes and less breast tenderness than combined hormone replacement therapy (HRT) preparations, and has also been shown to improve mood and libido in menopausal women, making it a unique and attractive option in younger women undergoing temporary, chemical menopause.
This is a prospective open-label observational cohort study. Pre-menopausal women over 18 years of age with known or suspected endometriosis or uterine fibroids who will be undergoing treatment with an injectable GnRH-agonist (leuprolide acetate) at the Royal Victoria Hospital (Glen site) will be recruited and screened for exclusion criteria. Consenting participants of the study will receive a phone call before their GnRH-a treatment to report menopausal symptoms and endometriosis symptoms in a baseline evaluation. After their GnRH-a treatment, participants will be contacted, by phone call, one, two and three months post treatment to be asked a standardized set of questions to evaluate relief of menopausal symptoms, control of endometriosis symptoms, as well as adherence to treatment, and side-effects. Add-back will commence one month after the initial injection of GnRH-a, such that the incidence of vasomotor symptoms and other side-effects of GnRH-a may be observed. In this way, this is a crossover study by design in which patients will serve as their own controls, before and after initiating add-back therapy with Tibolone. Participants will always reserve the right to commence Tibolone sooner than 1 month if they experience bothersome side-effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-menopausal women >18 years old with endometriosis and/or uterine fibroids | – | Drug: Tibolone 2.5 Mg Oral TabletGnRH-a depot (11.25mg IM x 1) and daily Tibolone 2.5mg orally once a day for 2-3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibolone 2.5 Mg Oral TabletAlso: LivialTibolone 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). | Drug | Pre-menopausal women >18 years old with endometriosis and/or uterine fibroids |
Primary outcome
Patient reported relief of menopausal symptoms
Time frame: Baseline
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.
Patient reported relief of menopausal symptoms
Time frame: 1 month following injection
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.
Patient reported relief of menopausal symptoms
Time frame: 2 months following injection
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.
Patient reported relief of menopausal symptoms
Time frame: 3 months following injection
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.
Patient reported sexual function
Time frame: Baseline
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.
Patient reported sexual function
Time frame: 1 month following injection
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.
Patient reported sexual function
Time frame: 2 months following injection
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.
Patient reported sexual function
Time frame: 3 months following injection
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.
10 secondary outcomes
Control of endometriosis symptoms
Time frame: Baseline
Control of endometriosis symptoms
Time frame: 1 month following injection
Control of endometriosis symptoms
Time frame: 2 months following injection
Control of endometriosis symptoms
Time frame: 3 months following injection
Tolerability of the regimen
Time frame: 1 month following injection
Tolerability of the regimen
Time frame: 2 months following injection
Tolerability of the regimen
Time frame: 3 months following injection
Incidence of major side effects
Time frame: 1 month following injection
Incidence of major side effects
Time frame: 2 months following injection
Incidence of major side effects
Time frame: 3 months following injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Zakhari, M.D. principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Fibroids, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 5 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: withdrawn, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Patient reported relief of menopausal symptoms (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2024.