Treatment of Menopausal Hot FlashesPhase 1NCT02070718
Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
A Phase 1 study testing Standard Dose Kappa Agonist and Half Dose Kappa Agonist in people with Treatment of Menopausal Hot Flashes, run by University of Washington at 1 site in United States.
Trial summary
Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs) may affect thermoregulation. This pilot study has the aim to establish proof of concept regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Treatment of Menopausal Hot Flashes
- What is being tested?
- Standard Dose Kappa Agonist and Half Dose Kappa Agonist
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jul 2013
- Phase
- Phase 1
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women 45-60 years of age; 12 months amenorrhea
- Documentation of > 8 moderate to severe, daily hot flashes during one week of baseline monitoring using daily diaries
- Availability of a family member or friend to drive participant home following clinic visits
Who cannot join
- Use of hormonal prescription medication or supplements for vasomotor symptoms (VMS)
- Use of narcotics
- Use of SSRI (selective serotonin reuptake inhibitor)/SNRI (serotonin-norepinephrine reuptake inhibitors), gabapentin, MAOI (monoamine oxidase inhibitor), anti-epileptics, sedatives
- History of polycystic ovarian syndrome or hirsutism
- Current history of depression
- Any chronic or acute medical illnesses including renal, hepatic, pulmonary diseases, or seizures
Show all 13Show fewer
- Substance abuse
- Severe corn allergy
- Known allergic reaction to pentazocine or naloxone
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Hysterectomy
- Use of anticholinergic medications
- Lactating or pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs) may affect thermoregulation. This pilot study has the aim to establish proof of concept regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.
Read the detailed description
To establish proof of concept regarding efficacy of an oral kappa agonist (KA), Pentazocine/ Naloxone 50/0.5 mg, for the treatment of menopausal hot flashes.
To gather data in support of a future proposal to study the safety and efficacy of a PRKA, a type of KA, for amelioration of menopausal hot flashes.
- Conditions
- Treatment of Menopausal Hot Flashes
- Being tested
- Standard Dose Kappa Agonist, Half Dose Kappa Agonist, Placebo
- Keywords
- hot flashes, menopause, kappa agonist
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Dose Kappa AgonistDrug
Also called Pentazocine/Naloxone 50/0.5 mg
Half Dose Kappa AgonistDrug
Also called Pentazocine/Naloxone 25/0.25 mg
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Cornstarch, National Formulary Receives: Other: Placebo |
| Standard Dose Kappa Agonist | Experimental | Pentazocine/Naloxone 50/0.5 mg Receives: Drug: Standard Dose Kappa Agonist |
| Half Dose Kappa Agonist | Experimental | Pentazocine/Naloxone 25/0.25 mg Receives: Drug: Half Dose Kappa Agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot Flashes
Objectively measured hot flash frequency by changes in skin conductance over 8 hours on 3 separate study visits 3-14 days apart.
Measured: 1-4 weeks
Secondary outcomes (2)
Subjectively measured hot flashes
Self-reported diary documentation of time and occurence of hot flashes and intensity of hot flashes over 8 hours on 3 separate study visits 3-14 days apart.
Measured: 1-4 weeks
Change in Serum Leutinizing Hormone
Serum collected at each visit baseline (before administration of treatment) and at 20-minute intervals over 8 hours on 3 separate study visits 3-14 days apart.
Measured: 1-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment of Menopausal Hot FlashesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH), Office of Research on Women's Health (ORWH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Susan Reed, University of Washington
- Investigators
- Susan D Reed, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070718
- Sponsor's protocol ID
- 43952-B
- Other IDs
- GYN-01-2012
- Status last verified
- Jun 2015
- First submitted
- 21 Feb 2014
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Oakley AE, Steiner RA, Chavkin C, Clifton DK, Ferrara LK, Reed SD. kappa Agonists as a novel therapy for menopausal hot flashes. Menopause. 2015 Dec;22(12):1328-34. doi: 10.1097/GME.0000000000000476.
PubMed 25988798
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
- ClinicalTrials.gov ID
- NCT02070718
- Acronym / sponsor ID
- 43952-B
- Conditions
- Treatment of Menopausal Hot Flashes
- Keywords
- hot flashes, menopause, kappa agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH), Office of Research on Women's Health (ORWH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Feb 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.
Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs) may affect thermoregulation. This pilot study has the aim to establish proof of concept regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.
Detailed description
To establish proof of concept regarding efficacy of an oral kappa agonist (KA), Pentazocine/ Naloxone 50/0.5 mg, for the treatment of menopausal hot flashes.
To gather data in support of a future proposal to study the safety and efficacy of a PRKA, a type of KA, for amelioration of menopausal hot flashes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboCornstarch, National Formulary |
| Standard Dose Kappa Agonist | Experimental | Drug: Standard Dose Kappa AgonistPentazocine/Naloxone 50/0.5 mg |
| Half Dose Kappa Agonist | Experimental | Drug: Half Dose Kappa AgonistPentazocine/Naloxone 25/0.25 mg |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women 45-60 years of age; 12 months amenorrhea
- Documentation of > 8 moderate to severe, daily hot flashes during one week of baseline monitoring using daily diaries
- Availability of a family member or friend to drive participant home following clinic visits
Key exclusion criteria (13 listed)
- Use of hormonal prescription medication or supplements for vasomotor symptoms (VMS)
- Use of narcotics
- Use of SSRI (selective serotonin reuptake inhibitor)/SNRI (serotonin-norepinephrine reuptake inhibitors), gabapentin, MAOI (monoamine oxidase inhibitor), anti-epileptics, sedatives
- History of polycystic ovarian syndrome or hirsutism
- Current history of depression
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 |
|---|---|---|
| Standard Dose Kappa AgonistAlso: Pentazocine/Naloxone 50/0.5 mg | Drug | Standard Dose Kappa Agonist |
| Half Dose Kappa AgonistAlso: Pentazocine/Naloxone 25/0.25 mg | Drug | Half Dose Kappa Agonist |
| Placebo | Other | Placebo |
Primary outcome
Hot Flashes
Time frame: 1-4 weeks
Objectively measured hot flash frequency by changes in skin conductance over 8 hours on 3 separate study visits 3-14 days apart.
2 secondary outcomes
Subjectively measured hot flashes
Time frame: 1-4 weeks
Change in Serum Leutinizing Hormone
Time frame: 1-4 weeks
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 1 Jul 2015.
- Derived from this study: PubMed 25988798Oakley AE, Steiner RA, Chavkin C, Clifton DK, Ferrara LK, Reed SD. kappa Agonists as a novel therapy for menopausal hot flashes. Menopause. 2015 Dec;22(12):1328-34. doi: 10.1097/GME.0000000000000476.
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A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer, Hot Flashes
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.
Susan D Reed, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Standard Dose Kappa Agonist and Half Dose Kappa Agonist in people with Treatment of Menopausal Hot Flashes, run by University of Washington at 1 site 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 3 inclusion and 13 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 1 Jul 2015. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Hot Flashes (time frame: 1-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02070718, which also lists 1 linked publication.
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 1 Jul 2015.