Vasomotor Symptoms (VMS)Phase 2NCT02049164
Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS)
A Phase 2 study testing AR08 in people with Vasomotor Symptoms (VMS), run by Arbor Pharmaceuticals, Inc. at 15 sites in United States.
Trial summary
The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females. Read more about this study
- Who is it for?
- Ages 41 years and older, women only
- Conditions the study is for
- Vasomotor Symptoms (VMS)
- What is being tested?
- AR08
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 15 sitesUnited States
- Study dates
- Jan 2014to May 2014
- 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 41 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally healthy female > 40 years of age with a body mass index (BMI) ≤ 40;
- Has undergone menopause defined as any of the following:
- At least 12 months of spontaneous amenorrhea; or At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; or At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy);
- Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week
Who cannot join
- Resting systolic blood pressure (SBP) <110 mmHg, resting diastolic blood pressure (DBP) <50 mm Hg, or a resting heart rate (HR) <60 beats per minute while awake;
- Subjects with pre-existing orthostatic hypotension at Screening;
- Use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modifier (SERM) -containing drug products within 8 weeks prior to Screening; use of transdermal hormone products within 8 weeks prior to Screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to Screening; use of intrauterine progestins within 8 weeks prior to Screening; use of progestin implants or estrogen injectables within 3 months prior to Screening; use of estrogen pellet or progestin injectables within 6 months prior to Screening;
- History of daily usage (at least 28 days/month) of either of the following during the month prior to initiation of Screening: Antihypertensives or Prophylactic antimigraine medications
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404
Clinical Research Advantage, Inc.
Colorado Springs, Colorado, 80906
Blue Skies Center for Women
Colorado Springs, Colorado, 80910
TMC Life Research, Inc.
Houston, Texas, 77054
Altus Research
Lakeworth, Florida, 99461
Clinical Research Center of Nevada
Las Vegas, Nevada, 89123
Lawrence OB/Gyn Associates
Lawrenceville, New Jersey, 08648
OB-GYN Associates of Mid-Florida, P.A.
Leesburg, Florida, 34748
Tidewater Physicians for Women
Norfolk, Virginia, 23502
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114
Genesis Center for Clinical Research
San Diego, California, 92103
Seattle Womens: Health, Research, Gynecology
Seattle, Washington, 98105
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Cypress Medical Research Center
Wichita, Kansas, 67226
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Forced Titration, Dose-ranging Study of AR08 in the Treatment of Vasomotor Symptoms (VMS) in Menopausal Females: A Proof-of-Concept Study
The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.
- Conditions
- Vasomotor Symptoms (VMS)
- Being tested
- AR08, Placebo
- Keywords
- AR08, Vasomotor Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR08Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AR08 0.5 mg/day | Experimental | AR08 QD oral dosing for 14 weeks Receives: Drug: AR08 |
| AR08 1.0 mg/day | Experimental | AR08 QD oral dosing for 14 weeks Receives: Drug: AR08 |
| AR08 2.0 mg/day | Experimental | AR08 QD oral dosing for 14 weeks Receives: Drug: AR08 |
| Placebo | Placebo comparator | Placebo QD oral dosing for 14 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from Baseline in the frequency and severity of moderate to severe hot flashes
Measured: Weeks 4 and 12
Secondary outcomes (1)
Patient Global Impression - Improvement (PGI-I)
Measured: Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Study stopping criteria met with regards to vital sign measurements post dose.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor Symptoms (VMS)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049164
- Sponsor's protocol ID
- AR08.100
- Status last verified
- Nov 2015
- First submitted
- 28 Jan 2014
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Forced Titration, Dose-ranging Study of AR08 in the Treatment of Vasomotor Symptoms (VMS) in Menopausal Females: A Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT02049164
- Acronym / sponsor ID
- AR08.100
- Conditions
- Vasomotor Symptoms (VMS)
- Keywords
- AR08, Vasomotor Symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopping criteria met with regards to vital sign measurements post dose.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Jan 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.
The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AR08 0.5 mg/day | Experimental | Drug: AR08AR08 QD oral dosing for 14 weeks |
| AR08 1.0 mg/day | Experimental | Drug: AR08AR08 QD oral dosing for 14 weeks |
| AR08 2.0 mg/day | Experimental | Drug: AR08AR08 QD oral dosing for 14 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo QD oral dosing for 14 weeks |
Who may qualify
- Ages
- 41 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Generally healthy female > 40 years of age with a body mass index (BMI) ≤ 40;
- Has undergone menopause defined as any of the following:
- At least 12 months of spontaneous amenorrhea; or At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; or At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy);
- Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week
Key exclusion criteria (4 listed)
- Resting systolic blood pressure (SBP) <110 mmHg, resting diastolic blood pressure (DBP) <50 mm Hg, or a resting heart rate (HR) <60 beats per minute while awake;
- Subjects with pre-existing orthostatic hypotension at Screening;
- Use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modifier (SERM) -containing drug products within 8 weeks prior to Screening; use of transdermal hormone products within 8 weeks prior to Screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to Screening; use of intrauterine progestins within 8 weeks prior to Screening; use of progestin implants or estrogen injectables within 3 months prior to Screening; use of estrogen pellet or progestin injectables within 6 months prior to Screening;
- History of daily usage (at least 28 days/month) of either of the following during the month prior to initiation of Screening: Antihypertensives or Prophylactic antimigraine medications
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 |
|---|---|---|
| AR08 | Drug | AR08 0.5 mg/day, AR08 1.0 mg/day, AR08 2.0 mg/day |
| Placebo | Drug | Placebo |
Primary outcome
Mean change from Baseline in the frequency and severity of moderate to severe hot flashes
Time frame: Weeks 4 and 12
1 secondary outcome
Patient Global Impression - Improvement (PGI-I)
Time frame: Weeks 4, 8, and 12
Results and safety
The study was stopped early (reason given: Study stopping criteria met with regards to vital sign measurements post dose.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR08 in people with Vasomotor Symptoms (VMS), run by Arbor Pharmaceuticals, Inc. at 15 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 4 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 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 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 was stopped early (reason given: Study stopping criteria met with regards to vital sign measurements post dose.). 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?
Mean change from Baseline in the frequency and severity of moderate to severe hot flashes (time frame: 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 9 Dec 2015.