PMSPhase 2RDCNCT02100540
A Study to Evaluate the Effects of RCN3028 on Moderate to Severe Vasomotor Symptoms in Women
A Phase 2 study testing II RDC 0.3mg capsule and III RDC 0.6mg capsule in people with PMS and Hot Flashes, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
Trial summary
Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause hypothermia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- PMS, Hot Flashes
- What is being tested?
- II RDC 0.3mg capsule and III RDC 0.6mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Mar 2014to 28 Sep 2017
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Menopausal (postmenopausal or perimenopausal) adult women who are suffering from vasomotor symptom or women who are suffering from drug (tamoxifen or aromatase inhibitors) induced vasomotor symptoms. Women have received postsurgical bilateral oophorectomy with or without hysterectomy will be eligible for the study;
- Women who are on tamoxifen or aromatase inhibitors, it has to be for at least 8 weeks at stable dosing and will maintain at the same treatment regimen during the study;
- Menopausal (postmenopausal or perimenopausal) adult women and drug (tamoxifen or aromatase inhibitors) induced vasomotor symptoms must average 3 or more moderate to severe hot flashes per day or 25 per week. Both based upon data obtained from a completed VMS episode event log for a 1 week period prior to randomization where moderate is defined as a sensation of heat with sweating, able to continue activity, and severe is defined as a sensation of heat with sweating, causing cessation of activity. Awake at night due to sweats will be recorded separately and will be considered as severe;
- Ability to understand and follow the instructions of the investigator, including completion of the VMS episode event logs (patient diary) as described in the protocol;
- Able and willing to provide written informed consent;
- Study participants should not be taking estrogen or a SERM alone or estrogen/progestin containing drug products. The following washout periods are recommended before baseline assessments are made for subjects previously on estrogen or a SERM alone or estrogen/progestin containing products:
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- 1 week for prior vaginal hormonal products (rings, creams, gels);
- ≥ 4 weeks for prior transdermal estrogen alone or estrogen/progestin products;
- ≥ 8 weeks for prior oral estrogen, SERM and/or progestin therapy;
- ≥ 8 weeks for prior intrauterine progestin therapy;
- ≥ 3 months for prior progestin implants and estrogen alone injectable drug therapy;
- ≥ 6 months for prior estrogen pellet therapy or progestin injectable drug therapy.
Who cannot join
- Hypertension with uncontrolled blood pressure (Systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg) Subjects with mild to moderate hypertension who are controlled on a stable antihypertension regimen may be enrolled if they meet the other inclusion/exclusion criteria;
- Use of SSRI and/or SNRI. Prior usage of herbal or dietary supplements, including black cohosh, soy, phytoestrogens will be eligible if subject agrees to cease taking above agents during the study;
- Subjects taking or having taken any other experimental drugs, or participating in or having participated in other clinical studies in the 30 days prior to this clinical trial;
- Subjects having a known history of allergic reaction, hypersensitivity or clinically significant intolerance to ingredients of the study drug;
- Subject has a history or suspicion of cancer with exception of breast cancer;
- Subjects with a current drug or alcohol abuse problem as judged by the investigator;
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- Subjects have clinical significant conditional, such as acute myocardial infarction or stroke with 6 months of randomization;
- Subjects have suicidal tendency;
- Subjects who are considered unreliable as to medication compliance or adherence to scheduled appointments or for other reasons are felt to be inappropriate for inclusion in the study as determined by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Dose-Response, Phase 2, -Study to Evaluate the Effects of RCN3028 on Moderate to Severe Vasomotor Symptoms in Women
Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause hypothermia. Risperidone is a potent 5-HT2A and a dopamine D2 receptor antagonist and is proposed to have effect on reduciton of hot flashes through its dopaminergic and serotonergic antagonism. The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
- Conditions
- PMS, Hot Flashes
- Being tested
- I placebo capsule, II RDC 0.3mg capsule, III RDC 0.6mg capsule
- Keywords
- PMS, hot flashes
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I placebo capsuleDrug
Also called RCN3028 placebo
I placebo capsule
II RDC 0.3mg capsuleDrug
Also called RCN3028 0.3mg capsule
II RDC 0.3mg capsule
III RDC 0.6mg capsuleDrug
Also called RCN3028 0.6mg capsule
III RDC 0.6mg capsule
| Study group | Role | What they receive |
|---|---|---|
| I placebo capsule | Placebo comparator | I placebo capsule Receives: Drug: I placebo capsule |
| II RDC 0.3mg capsule | Experimental | II RDC 0.3mg capsule Receives: Drug: II RDC 0.3mg capsule |
| III RDC 0.6mg capsule | Experimental | III RDC 0.6mg capsule Receives: Drug: III RDC 0.6mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in frequency of moderate to severe vasomotor symptoms
Measured: baseline to weeks 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study start19 Mar 2014
- Primary completion23 Mar 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PMSStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Changhua Christian Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100540
- Sponsor's protocol ID
- YSP-RCN3028-01
- Acronym
- RDC
- Status last verified
- Feb 2022
- First submitted
- 26 Mar 2014
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Dose-Response, Phase 2, -Study to Evaluate the Effects of RCN3028 on Moderate to Severe Vasomotor Symptoms in Women
- ClinicalTrials.gov ID
- NCT02100540
- Acronym / sponsor ID
- RDC / YSP-RCN3028-01
- Conditions
- PMS, Hot Flashes
- Keywords
- PMS, hot flashes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Changhua Christian Hospital
- Study start
- 19 Mar 2014 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 1 Apr 2014 (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.
Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause hypothermia. Risperidone is a potent 5-HT2A and a dopamine D2 receptor antagonist and is proposed to have effect on reduciton of hot flashes through its dopaminergic and serotonergic antagonism. The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I placebo capsule | Placebo comparator | Drug: I placebo capsuleI placebo capsule |
| II RDC 0.3mg capsule | Experimental | Drug: II RDC 0.3mg capsuleII RDC 0.3mg capsule |
| III RDC 0.6mg capsule | Experimental | Drug: III RDC 0.6mg capsuleIII RDC 0.6mg capsule |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Menopausal (postmenopausal or perimenopausal) adult women who are suffering from vasomotor symptom or women who are suffering from drug (tamoxifen or aromatase inhibitors) induced vasomotor symptoms. Women have received postsurgical bilateral oophorectomy with or without hysterectomy will be eligible for the study;
- Menopausal (postmenopausal or perimenopausal) adult women and drug (tamoxifen or aromatase inhibitors) induced vasomotor symptoms must average 3 or more moderate to severe hot flashes per day or 25 per week. Both based upon data obtained from a completed VMS episode event log for a 1 week period prior to randomization where moderate is defined as a sensation of heat with sweating, able to continue activity, and severe is defined as a sensation of heat with sweating, causing cessation of activity. Awake at night due to sweats will be recorded separately and will be considered as severe;
- Ability to understand and follow the instructions of the investigator, including completion of the VMS episode event logs (patient diary) as described in the protocol;
- Able and willing to provide written informed consent;
- Study participants should not be taking estrogen or a SERM alone or estrogen/progestin containing drug products. The following washout periods are recommended before baseline assessments are made for subjects previously on estrogen or a SERM alone or estrogen/progestin containing products:
Key exclusion criteria (9 listed)
- Hypertension with uncontrolled blood pressure (Systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg) Subjects with mild to moderate hypertension who are controlled on a stable antihypertension regimen may be enrolled if they meet the other inclusion/exclusion criteria;
- Use of SSRI and/or SNRI. Prior usage of herbal or dietary supplements, including black cohosh, soy, phytoestrogens will be eligible if subject agrees to cease taking above agents during the study;
- Subjects taking or having taken any other experimental drugs, or participating in or having participated in other clinical studies in the 30 days prior to this clinical trial;
- Subjects having a known history of allergic reaction, hypersensitivity or clinically significant intolerance to ingredients of the study drug;
- Subject has a history or suspicion of cancer with exception of breast cancer;
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 |
|---|---|---|
| I placebo capsuleAlso: RCN3028 placeboI placebo capsule | Drug | I placebo capsule |
| II RDC 0.3mg capsuleAlso: RCN3028 0.3mg capsuleII RDC 0.3mg capsule | Drug | II RDC 0.3mg capsule |
| III RDC 0.6mg capsuleAlso: RCN3028 0.6mg capsuleIII RDC 0.6mg capsule | Drug | III RDC 0.6mg capsule |
Primary outcome
Mean change in frequency of moderate to severe vasomotor symptoms
Time frame: baseline to weeks 4 and 12
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 14 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing II RDC 0.3mg capsule and III RDC 0.6mg capsule in people with PMS and Hot Flashes, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
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 12 inclusion and 9 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 14 Feb 2022. 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 Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean change in frequency of moderate to severe vasomotor symptoms (time frame: baseline to weeks 4 and 12). 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 14 Feb 2022.