PerimenopausePhase 3NCT02779582
Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow
A Phase 3 study testing Oral Micronized Progesterone in people with Perimenopause and Menstrual Cramps, run by University of British Columbia at 1 site in Canada.
Trial summary
This study is designed to evaluate the within-woman effect of oral micronized progesterone (Progesterone 300 mg at bedtime) on semi-quantitative menstrual flow measured by the DivaCup® (menstrual cup with volume indicators at 7.5, 15 and 30 ml) or by counting the number of soaked normal-sized sanitary products such as… Read more about this study
- Who is it for?
- Ages 35 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause, Menstrual Cramps
- What is being tested?
- Oral Micronized Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to 1 Jun 2018
- Phase
- Phase 3
- 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 35 to 58 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- >35 to <58 years of age
- Willingness to participate in this sub-study
- Perimenopausal status either based on irregularity of menstrual periods, or by onset of hot flushes/night sweats in women with regular periods
- Ability and willingness to complete the -flow recording instrument
- Ability to understand, speak, read and write English.
Who cannot join
- Less than 35 or greater than 58 years of age
- More than 1-yr without menstrual flow at study enrollment, including those with a hysterectomy ± ovariectomy
- Peanut allergy (because peanut oil is used in the progesterone formulation)
- Current or recent (within 6-mo of study enrollment) use of hormonal therapies (estrogen, progesterone, progestin-releasing intrauterine device (IUD), hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period
- Planned pregnancy or fertility treatment during the study period
- Inability to understand, speak, read and write English
Trial locations and contacts
1 site in 1 country.
Canada1 site
Participation from home or in-person at University of British Columbia/Centre for Menstrual Cycle and Ovulation Research (CeMCOR)/Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow: A Randomized, Double-masked, Placebo-controlled Trial
This study is designed to evaluate the within-woman effect of oral micronized progesterone (Progesterone 300 mg at bedtime) on semi-quantitative menstrual flow measured by the DivaCup® (menstrual cup with volume indicators at 7.5, 15 and 30 ml) or by counting the number of soaked normal-sized sanitary products such as normal-sized tampons or pads as well as length of flow and frequency and severity of menstrual cramps (on a 0-4 scale) in women with hot flushes and night sweats who are qualified to enroll in the primary perimenopausal hot flush trial stratified by whether they are in Early or Late Perimenopause.
Read the detailed description
The study will be a double-masked, placebo-controlled 28-day (4 week) baseline, 84-day (12 week) experimental trial, with a maximum number of 125 potential enrollees, with stratified random therapy assignment by Early or Late Perimenopause. Participants who meet the inclusion criteria for the original Progesterone for Perimenopausal Vasomotor Symptoms Study will be invited to join this additional sub-study. As part of the primary trial they will be randomly assigned into either the Progesterone or placebo group on a 1:1 basis. Primary and secondary data will be collected continuously throughout the study by completion of the Daily Perimenopause Diary-flow starting at baseline and continuously throughout the study.
- Conditions
- Perimenopause, Menstrual Cramps
- Being tested
- Oral Micronized Progesterone, Placebo
- Keywords
- Progesterone, Menstrual Flow
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Micronized ProgesteroneDrug
Also called progesterone
The dose of 300 mg of Progesterone is a physiological one that maintains the serum progesterone at or above the luteal (normal post-ovulatory) threshold for 24 hours. This duration of action is important because Progesterone is not safely taken during waking hours because of its soporific effects.
PlaceboDrug
pill with no effect
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Experimental | Oral micronized progesterone, 300 mg po daily, taken as three capsules daily before sleep for three months Receives: Drug: Oral Micronized Progesterone |
| Placebo | Placebo comparator | Placebo, each taken as three capsules daily before sleep for three months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of menstrual fluid
Measured: daily for four months
Secondary outcomes (2)
Number of days of flow
Measured: daily for four months
Severity of menstrual cramps measured by a self-reported scale between zero and four (i.e. zero means 'no cramps' and four means 'very intense cramps')
Measured: daily for fourth months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJun 2015
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerilynn Prior, University of British Columbia
- Investigators
- Jerilynn C Prior, MD, FRCPC, Principal investigator, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779582
- Sponsor's protocol ID
- H10-02975_1
- Status last verified
- Mar 2020
- First submitted
- 10 Dec 2015
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow: A Randomized, Double-masked, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02779582
- Acronym / sponsor ID
- H10-02975_1
- Conditions
- Perimenopause, Menstrual Cramps
- Keywords
- Progesterone, Menstrual Flow
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 20 May 2016 (estimated)
- 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.
This study is designed to evaluate the within-woman effect of oral micronized progesterone (Progesterone 300 mg at bedtime) on semi-quantitative menstrual flow measured by the DivaCup® (menstrual cup with volume indicators at 7.5, 15 and 30 ml) or by counting the number of soaked normal-sized sanitary products such as normal-sized tampons or pads as well as length of flow and frequency and severity of menstrual cramps (on a 0-4 scale) in women with hot flushes and night sweats who are qualified to enroll in the primary perimenopausal hot flush trial stratified by whether they are in Early or Late Perimenopause.
Detailed description
The study will be a double-masked, placebo-controlled 28-day (4 week) baseline, 84-day (12 week) experimental trial, with a maximum number of 125 potential enrollees, with stratified random therapy assignment by Early or Late Perimenopause. Participants who meet the inclusion criteria for the original Progesterone for Perimenopausal Vasomotor Symptoms Study will be invited to join this additional sub-study. As part of the primary trial they will be randomly assigned into either the Progesterone or placebo group on a 1:1 basis. Primary and secondary data will be collected continuously throughout the study by completion of the Daily Perimenopause Diary-flow starting at baseline and continuously throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Experimental | Drug: Oral Micronized ProgesteroneOral micronized progesterone, 300 mg po daily, taken as three capsules daily before sleep for three months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, each taken as three capsules daily before sleep for three months |
Who may qualify
- Ages
- 35 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- >35 to <58 years of age
- Willingness to participate in this sub-study
- Perimenopausal status either based on irregularity of menstrual periods, or by onset of hot flushes/night sweats in women with regular periods
- Ability and willingness to complete the -flow recording instrument
- Ability to understand, speak, read and write English.
Key exclusion criteria (6 listed)
- Less than 35 or greater than 58 years of age
- More than 1-yr without menstrual flow at study enrollment, including those with a hysterectomy ± ovariectomy
- Peanut allergy (because peanut oil is used in the progesterone formulation)
- Current or recent (within 6-mo of study enrollment) use of hormonal therapies (estrogen, progesterone, progestin-releasing intrauterine device (IUD), hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period
- Planned pregnancy or fertility treatment during the study period
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 |
|---|---|---|
| Oral Micronized ProgesteroneAlso: progesteroneThe dose of 300 mg of Progesterone is a physiological one that maintains the serum progesterone at or above the luteal (normal post-ovulatory) threshold for 24 hours. This duration of action is important because Progesterone is not safely taken during waking hours because of its soporific effects. | Drug | Progesterone |
| Placebopill with no effect | Drug | Placebo |
Primary outcome
Amount of menstrual fluid
Time frame: daily for four months
2 secondary outcomes
Number of days of flow
Time frame: daily for four months
Severity of menstrual cramps measured by a self-reported scale between zero and four (i.e. zero means 'no cramps' and four means 'very intense cramps')
Time frame: daily for fourth months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Perimenopause
Not yet recruitingPhase 4
Migraine Menopause Study
Migraine, Menopausal
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
RecruitingObservational study
The Immunobiological Mechanisms of Depression in Perimenopause
Perimenopause, Major Depressive Episode (MDE)
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Recruiting
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
Chronic Insomnia During Perimenopause and Menopause
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.
Jerilynn C Prior, MD, FRCPC principal investigator
UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Micronized Progesterone in people with Perimenopause and Menstrual Cramps, run by University of British Columbia 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 6 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: finished, as of the sponsor's last update on 24 Mar 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of menstrual fluid (time frame: daily for four months). 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 24 Mar 2020.