Climacteric; Menorrhagia, MenopausalNCT03704454
The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
A study of Climacteric; Menorrhagia, Menopausal and Menopause, run by Legacy Health System at 3 sites in United States.
Trial summary
This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Climacteric; Menorrhagia, Menopausal, Menopause
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2018to 15 Sep 2020
- Phase
- Interventional
- 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 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient currently is undergoing treatment for cancer
- Patient has menopausal symptoms induced either by surgical or medical (patient on tamoxifen or aromatase inhibitor) interventions for cancer
- > 18 years of age
- Willing to travel to a Legacy Health facility if necessary
- Agree to attend study visits outside of standard of care visits, if needed
- Willing to stop other supplements or medications that are aimed at treating menopausal symptoms at least 7 days before beginning study treatment
- Willing to engage in pre/post testing and survey/phone calls
Who cannot join
- Patient is currently undergoing chemotherapy treatment
- < 18 years of age
- Unable to comply with protocol
- Unable to provide written informed consent
- Investigator does not believe study participation is in the best interest of the patient
- Patient had concurrent menopausal symptoms prior to the start of cancer treatment
- Menopausal symptoms are unrelated to surgical or medical treatment of breast or gynecologic cancers
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Legacy Mt. Hood Medical Center
Gresham, Oregon, 97030
Meg Christ, 503-413-8199, oncologyresearch@lhs.org
- Recruiting
Legacy Good Samaritan Medical Center
Portland, Oregon, 97219
Meg Christ, 503-413-8199, oncologyresearch@lhs.org
- Recruiting
Legacy Meridian Park Medical Center
Tualatin, Oregon, 97062
Meg Christ, 503-413-8199, oncologyresearch@lhs.org
About this study
This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.
- Conditions
- Climacteric; Menorrhagia, Menopausal, Menopause
- Being tested
- 50 mg PYC and then placebo, 100 mg PYC and then placebo, Placebo and then 50 mg PYC, Placebo and then 100 mg PYC
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg PYC and then placeboDietary supplement
4 weeks on PYC, then 4 weeks on placebo
100 mg PYC and then placeboDietary supplement
4 weeks on PYC, then 4 weeks on placebo
Placebo and then 50 mg PYCDietary supplement
4 weeks on placebo, then 4 weeks on PYC
Placebo and then 100 mg PYCDietary supplement
4 weeks on placebo, then 4 weeks of PYC
| Study group | Role | What they receive |
|---|---|---|
| Group A - PYC & Placebo | Experimental | 50 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks Receives: Dietary Supplement: 50 mg PYC and then placebo |
| Group B - PYC & Placebo | Experimental | 100 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks Receives: Dietary Supplement: 100 mg PYC and then placebo |
| Group C - Placebo & PYC | Experimental | Placebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks Receives: Dietary Supplement: Placebo and then 50 mg PYC |
| Group D - Placebo & PYC | Experimental | Placebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks Receives: Dietary Supplement: Placebo and then 100 mg PYC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Rating Scale (MRS)
The MRS will be used to evaluate the efficacy of PYC in decreasing menopausal symptoms as compared to placebo. The difference-from-baseline (DFB) score will be calculated by taking the composite MRS score at 10 weeks and 12 weeks compared to the MRS score at baseline to determine whether or not PYC reduces symptoms, if the effects last beyond actively taking PYC, and if so, how long. The purpose of multiple time point assessments is two-fold: first, some patients will be taking placebo and some will be taking active drug in the first month, and vice versa during the second month. Therefore, an assessment needs to be done at each timepoint, weeks 4 and 8. Second, we are interested in understanding how long the symptoms management may last without actively taking drug, which accounts for the 10 week and 12 week timepoints.
Measured: The MRS will be administered at baseline, after 4 weeks, after 8 weeks, 2 week follow-up (10 weeks), and 1 month follow up (12 weeks) with the intention of calculating DFB score at each time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Oct 2018
- Primary completion15 Sep 2019 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Climacteric; Menorrhagia, MenopausalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Antoszewska, Legacy Health System
- Investigators
- Reza Antoszewska, NP-C, Principal investigator, Legacy Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704454
- Sponsor's protocol ID
- PYC001
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
- ClinicalTrials.gov ID
- NCT03704454
- Acronym / sponsor ID
- PYC001
- Conditions
- Climacteric; Menorrhagia, Menopausal, Menopause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Sep 2019 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 12 Oct 2018 (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.
This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A - PYC & Placebo | Experimental | Dietary Supplement: 50 mg PYC and then placebo50 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks |
| Group B - PYC & Placebo | Experimental | Dietary Supplement: 100 mg PYC and then placebo100 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks |
| Group C - Placebo & PYC | Experimental | Dietary Supplement: Placebo and then 50 mg PYCPlacebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks |
| Group D - Placebo & PYC | Experimental | Dietary Supplement: Placebo and then 100 mg PYCPlacebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient currently is undergoing treatment for cancer
- Patient has menopausal symptoms induced either by surgical or medical (patient on tamoxifen or aromatase inhibitor) interventions for cancer
- > 18 years of age
- Willing to travel to a Legacy Health facility if necessary
- Agree to attend study visits outside of standard of care visits, if needed
Key exclusion criteria (7 listed)
- Patient is currently undergoing chemotherapy treatment
- < 18 years of age
- Unable to comply with protocol
- Unable to provide written informed consent
- Investigator does not believe study participation is in the best interest of the patient
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 |
|---|---|---|
| 50 mg PYC and then placebo4 weeks on PYC, then 4 weeks on placebo | Dietary supplement | Group A - PYC & Placebo |
| 100 mg PYC and then placebo4 weeks on PYC, then 4 weeks on placebo | Dietary supplement | Group B - PYC & Placebo |
| Placebo and then 50 mg PYC4 weeks on placebo, then 4 weeks on PYC | Dietary supplement | Group C - Placebo & PYC |
| Placebo and then 100 mg PYC4 weeks on placebo, then 4 weeks of PYC | Dietary supplement | Group D - Placebo & PYC |
Primary outcome
Menopause Rating Scale (MRS)
Time frame: The MRS will be administered at baseline, after 4 weeks, after 8 weeks, 2 week follow-up (10 weeks), and 1 month follow up (12 weeks) with the intention of calculating DFB score at each time point.
The MRS will be used to evaluate the efficacy of PYC in decreasing menopausal symptoms as compared to placebo. The difference-from-baseline (DFB) score will be calculated by taking the composite MRS score at 10 weeks and 12 weeks compared to the MRS score at baseline to determine whether or not PYC reduces symptoms, if the effects last beyond actively taking PYC, and if so, how long. The purpose of multiple time point assessments is two-fold: first, some patients will be taking placebo and some will be taking active drug in the first month, and vice versa during the second month. Therefore, an assessment needs to be done at each timepoint, weeks 4 and 8. Second, we are interested in understanding how long the symptoms management may last without actively taking drug, which accounts for the 10 week and 12 week timepoints.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
Related trials for Climacteric; Menorrhagia, Menopausal
Not yet recruiting
How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?
Iron Deficiency Anemia Treatment, Iron Deficiency
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.
Reza Antoszewska, NP-C principal investigator
Legacy Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Climacteric; Menorrhagia, Menopausal and Menopause, run by Legacy Health System at 3 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meg Christ (503-413-8199, mchrist@lhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause Rating Scale (MRS) (time frame: The MRS will be administered at baseline, after 4 weeks, after 8 weeks, 2 week follow-up (10 weeks), and 1 month follow up (12 weeks) with the intention of calculating DFB score at each time point.). 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 12 Oct 2018.