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MenopauseMOMENTNCT07618039

MOving Forward With MENopause Treatment Through Pharmacists' Expanded Roles in Hormone Health

An observational study of Menopause and Pharmacists, run by Dalhousie University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The MOMENT project centres pharmacists as key partners for people assigned female at birth (AFAB) in improving menopause care. Menopause is a major life event, which half of our population will experience. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Menopause, Pharmacists
What is being tested?
Pharmacist-led menopause care
How many people
200 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: There are two groups in the study: 1) pharmacist participants, and 2) AFAB participants experiencing signs and symptoms of the menopause transition and menopause attributable to declining hormone levels (e.g., estrogen, progesterone). Pharmacist participants: Pharmacist participants will be employed at a community pharmacy that has a practice setting that includes appointment based pharmacy services. AFAB participants seeking care for menopause-related symptoms may be eligible.

Who may be able to join

  • Pharmacist (pharmacies) participants:
  • Select community pharmacies with an appointment based system as chosen in consultation with PANS.
  • Pharmacist participants must be licensed to practice direct patient care in Nova Scotia.
  • Pharmacist participants must have completed the MOMENT education and training.
  • Patient participants:
  • Resident of Nova Scotia with a provincial MSI card.
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  • People with the anatomical and physiological components (AFAB) that would predispose them to signs and symptoms of menopause that are associated with decreasing hormones (e.g., estrogen).
  • Signs and/or symptoms of the menopause and the person is seeking care for the same, regardless of whether they are using treatments.
  • The potential participants will screen using MQ6 questions based on: 1) changes in periods; 2) presence of hot flashes; 3) vaginal dryness, pain, or sexual concerns; 4) bladder issues or incontinence; 5) new sleep difficulties; 6) new or increased anxiety, irritability, depression or low mood.
  • People with symptoms in 2, 3, or 4 indicate symptoms for which MHT may be indicated and are eligible to be included for the study.
  • People with only number 1 should talk with the pharmacist to determine if these symptoms are related to menopause and what the menstrual changes are (i.e. frequency, volume, regularity, duration, non-menstrual bleeding, bleeding outside of the reproductive age, acute or chronic bleeding). If there is evidence of other signs and symptoms of menopause on assessment, they can be included. If no other signs or symptoms related to menopause are present, people will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https://www.nshealth.ca/wheretogoforhealthcare).
  • People only with 5 can be considered as part of common ailments prescribing (existing scope within the Standards of Practice for Prescribing Drugs), if appropriate, and will be included in the study only if other signs and symptoms of menopause are present.
  • People only with number 6 will be assessed regarding their symptoms. If no other signs or symptoms related to menopause are present, people will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https://www.nshealth.ca/wheretogoforhealthcare) and options for mental health care if deemed appropriate (https://mha.nshealth.ca/en). Additionally, the pharmacist can determine if there are options within their existing scope to provide care to the patient, if appropriate, and also refer the patient to a Bloom Program pharmacy if deemed appropriate.
  • Perimenopausal people who previously had symptoms of menopause and were also receiving hormonal contraceptives but warrant a transition to MHT based on clinical factors (e.g., older age, reached menopause).

Who cannot join

  • Patient participants:
  • People with surgical menopause via oophorectomy.
  • o Patients who have had oophorectomy experience early menopause (i.e., surgical menopause). These patients are most likely to have previously received or currently be receiving systemic treatment with MHT. If this was not the case, pharmacists will refer the patient back to their regular primary care provider, if the patient has one. If not, the pharmacist will provide the person with information on care options (e.g., https://www.nshealth.ca/wheretogoforhealthcare).
  • o If the pharmacist deems that a renewal of previous MHT is appropriate, they will use their clinical discretion and follow their legal and ethical obligations as per usual when engaging in this activity.
  • People with a final menstrual period (FMP) < 40 years or "early menopause" (FMP <45 years).
  • o additional investigation is required to explore underlying causes related to their menstrual cessation (e.g., hypothalamic-pituitary-ovarian axis conditions or other possible causes). People in this category will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https://www.nshealth.ca/wheretogoforhealthcare). Typically, people in this situation are typically treated with hormones to around the age of 51 (i.e. typical age of menopause).
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  • o Note: a person that had premature or early menopause and has progressed beyond the typical age of treatment for replacement of hormones (i.e., 51), and is currently experiencing signs and symptoms via screening, can be considered for inclusion.
  • Perimenopausal people who are seeking contraception prescribing.
  • o Pharmacists should engage in prescribing for contraceptive management as per the Nova Scotia College of Pharmacists Standards of Practice for Prescribing Drugs.
  • People who are stable on existing MHT and other therapies to manage menopausal symptoms and no changes are required.
  • People who only require a renewal, adaptation, or therapeutic substitution for a menopausal treatment. These activities fall within pharmacists' existing scope.
  • o Exception: people who do not have a doctor or nurse practitioner are eligible for inclusion if the pharmacist has been providing these prescribing services.
  • GSM induced by testosterone therapy for gender affirming care. o Transmasculine or gender diverse individuals using testosterone therapy with GSM induced by testosterone therapy (these people should be managed in collaboration with their gender affirming care providers).
  • The person cannot consent for themselves for the study due to cognitive impairment (e.g., advanced Alzheimer's disease or other dementias).
  • Considerations related to inclusion and exclusion criteria:
  • Older age: older age is not necessarily an exclusion criteria but will have a role as "a flag" in clinical assessment.
  • o People AFAB who are > 10 years after their FMP or > 60 years of age are not globally initiated on systemic MHT if they have have symptoms and have never had MHT before. However, there must be a benefit-risk discussion with the person regarding the treatment options if treatment is being sought, and therapies must be individualized. Although, "second-line", there are other systemic non-MHT options available for symptom management and other treatments (e.g., localized treatments such as intravaginal hormones for GSM). Regardless of the treatment, a benefit-risk discussion is required with the person AFAB.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Andrea L Murphy contact

1-833-866-6368

menopause@dal.ca

About this study

The MOMENT project centres pharmacists as key partners for people assigned female at birth (AFAB) in improving menopause care. Menopause is a major life event, which half of our population will experience. For many, the mental and physical symptoms of menopause can impact quality of life, relationships, and workplace productivity. There are significant inequities in menopause health care and knowledge gaps for health care providers and the public with menopause being poorly understood. Menopausal Hormone Therapy (MHT) and related treatments are under-utilized and symptom control for people AFAB is often suboptimal. Since the publication of the Women's Health Initiative (WHI) study of postmenopausal women in 2002, menopausal care changed and misinformation about the risks versus benefits of MHT continue to create fear in those AFAB and health care providers. Guideline-concordant care includes MHT as first-line therapies for symptoms and there is increasing interest to improve the care of menopausal people. When MHT is not appropriate, there are other non-hormonal options that are available.

What do pharmacists already legally do in Nova Scotia for hormone therapies and other treatments commonly used for menopausal management for those assigned female at birth?

Read more
  • Hormones and non-hormonal therapies: Pharmacists receive prescriptions for and dispense MHT and other therapies related to menopausal symptoms, and as per the Standards of Practice, assess appropriateness of all prescriptions for patients, which includes, but is not limited to, assessing indications, contraindications, dosing and intervals, drug interactions (drug-drug, drug-disease, drug-food, etc.), and providing education on the medication, including but not limited to its proper use and storage, expectations of side effects and benefits, how to monitor progress, and when to follow-up and seek help. Pharmacists have a relationship and responsibility to patients for shared decision making. This requires that they know the benefits (e.g., symptom reduction, health outcome reduction or improvement) and risks (e.g., adverse effects, contraindications, drug interactions) of hormones, and in the specific patient context.
  • Pharmacists can prescribe MHT and other non-hormonal therapies with a diagnosis as set out in collaboration with another health care professional (e.g., physicians, nurse practitioners) as per the existing legal framework in Nova Scotia.
  • Pharmacists provide ongoing care and monitoring throughout a patient's medication journey.
  • Pharmacists engage in prescribing renewals and therapeutic substitutions. They assume the prescribing responsibility when deciding to lengthen the time a patient can receive the prescription after it was initially prescribed by another prescriber, and when changing, adapting, or substituting medications as clinically indicated.
  • Pharmacists prescribe hormones for contraception.
  • Pharmacists can also prescribe non-MHT medications for other conditions related to menopause (e.g., insomnia) and recommend nonpharmacological interventions (e.g., cognitive behavioural therapy for insomnia, CBTi) as this is already part of the scope of practice.

What is the project proposing? This project will focus on initiation of treatments for menopausal symptoms (e.g., MHT and other guideline-concordant treatments) for AFAB participants as a part of menopause signs' and symptoms' management and adds initiation to other participant pharmacist prescribing responsibilities as described above.

The Pharmacy Association of Nova Scotia will facilitate communications to pharmacies and pharmacists, to request participation in the project. This will go to community pharmacies that have a practice setting that includes dedicated time for appointment-based prescribing services. For brevity, the investigators refer to these as appointment-based pharmacies (ABPs). The additional prescribing responsibilities will be facilitated through the existing legal framework in Nova Scotia. This means that it would be considered "Prescribing in Accordance with an Approved Research or Pilot Protocol" according to the existing regulatory framework within the Nova Scotia Pharmacy Regulator.

The project includes mixed methods with quantitative and qualitative approaches. The main sources of data will be anonymized data capture by pharmacist participants, surveys of both pharmacist participants and patient participants, and interviews of both groups of participants (i.e., pharmacist participants and patient participants).

Initiating treatments for menopause based on the current scope of practice is a natural progression of the scope of pharmacists' practice. It provides the opportunity to improve the health of those with menopausal signs and symptoms. The project can explore feasibility of an additional MHT prescriber in the health system and whether scale and spread should be explored further.

Being tested
Pharmacist-led menopause care
Keywords
pharmacists, menopause, implementation, access, menopause hormone therapy, genitourinary syndrome of menopause, vasomotor symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacist-led menopause careOther

    There are two groups in the study:

    1. pharmacists, and 2) people AFAB experiencing signs and symptoms of the menopause transition and menopause attributable to declining hormone levels (e.g., estrogen, progesterone).

    Pharmacists will be employed at a community pharmacy that has a practice setting that includes appointment based pharmacy services. These will be recruited with the assistance of the Pharmacy Association of Nova Scotia (PANS). 10 pharmacies will be selected based on factors such as knowledge regarding capacity, other existing health system variables, and geographical services and needs based on existing research and knowledge of service priorities. Pharmacists will provide services within scope and those approved for the study based on approval from the Nova Scotia Pharmacy Regulator.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants receiving care from participating pharmacists

    number of participants will be tracked at each pharmacy

    Measured: From enrollment through study completion, an average of 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07618039
Sponsor's protocol ID
REB 2025-7730
Acronym
MOMENT
Status last verified
May 2026
First submitted
21 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • www.menopausepharmacy.ca/

Questions about this trial

What is this clinical trial studying?

An observational study of Menopause and Pharmacists, run by Dalhousie University.

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 14 inclusion and 17 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: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea L Murphy (1-833-866-6368, menopause@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants receiving care from participating pharmacists (time frame: From enrollment through study completion, an average of 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07618039, which also lists 1 linked publication.

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 1 Jun 2026.

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