MenopausePhase 2/3NCT02497560
A Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms
A Phase 2/3 study testing proprietary formula in people with Menopause, run by Physician Recommended Nutriceuticals at 2 sites in United States.
Trial summary
This is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- proprietary formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2015to Mar 2017
- Phase
- Phase 2/3
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age group between 45 and 65 at the time of informed consent.
- Physician diagnosis of menopause.
- History of substantial hot flashes > 4 episodes /day for last 2 weeks.
- Being post-menopausal with an intact uterus.
- Subject has provided signed and dated written informed consent before admission to the study.
Who cannot join
- Concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit.
- Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future.
- Women involved in other clinical studies within the last 30 days.
- Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Comprehensive Women's Care
Colorado Springs, Colorado, 80910
Dittrich Clinic
Philadelphia, Pennsylvania, 19148
About this study
Official title: A Randomized Double Blind Placebo-Controlled Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms
This is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women.
- Conditions
- Menopause
- Being tested
- proprietary formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprietary formulaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | all natural dietary supplement Receives: Dietary Supplement: proprietary formula |
| Treatment + Omega-3s | Other | all natural dietary supplement + omega-3s Receives: Dietary Supplement: proprietary formula |
| Placebo | Placebo comparator | vegetable oil Receives: Dietary Supplement: proprietary formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot flashes episodes
Diary
Measured: 12 weeks
Secondary outcomes (2)
Work productivity
Questionnaire
Measured: 12 weeks
Quality of Life
Questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
Why it stopped: Role of calcium in menopause is not clear. Product maybe reformulated and the study relaunched.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physician Recommended Nutriceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497560
- Sponsor's protocol ID
- PRN 20144
- Status last verified
- Aug 2016
- First submitted
- 6 Jul 2015
- Last updated
- 4 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Placebo-Controlled Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT02497560
- Acronym / sponsor ID
- PRN 20144
- Conditions
- Menopause
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Role of calcium in menopause is not clear. Product maybe reformulated and the study relaunched.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Physician Recommended NutriceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- First posted
- 14 Jul 2015 (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 is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Dietary Supplement: proprietary formulaall natural dietary supplement |
| Treatment + Omega-3s | Other | Dietary Supplement: proprietary formulaall natural dietary supplement + omega-3s |
| Placebo | Placebo comparator | Dietary Supplement: proprietary formulavegetable oil |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age group between 45 and 65 at the time of informed consent.
- Physician diagnosis of menopause.
- History of substantial hot flashes > 4 episodes /day for last 2 weeks.
- Being post-menopausal with an intact uterus.
- Subject has provided signed and dated written informed consent before admission to the study.
Key exclusion criteria (4 listed)
- Concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit.
- Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future.
- Women involved in other clinical studies within the last 30 days.
- Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.
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 |
|---|---|---|
| proprietary formula | Dietary supplement | Placebo, Treatment, Treatment + Omega-3s |
Primary outcome
Hot flashes episodes
Time frame: 12 weeks
Diary
2 secondary outcomes
Work productivity
Time frame: 12 weeks
Quality of Life
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Role of calcium in menopause is not clear. Product maybe reformulated and the study relaunched.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing proprietary formula in people with Menopause, run by Physician Recommended Nutriceuticals at 2 sites in United States.
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 4 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: stopped early, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Role of calcium in menopause is not clear. Product maybe reformulated and the study relaunched.). Results are not available in the source record.
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?
Hot flashes episodes (time frame: 12 weeks). 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 4 Aug 2016.