Menopause SyndromePhase 2MENOXTINANCT06763484
Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause
A Phase 2 study testing Paroxetine in people with Menopause Syndrome and Menopause Surgical, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
Trial summary
evaluate the efficacy of paroxetine in the management of vasomotor symptoms in patients with surgical menopause, in order to seek an alternative therapy to hormone therapy, which is associated with proinflammatory and procoagulant effects that increase the risk of thrombosis and is therefore contraindicated in people… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause Syndrome, Menopause Surgical, Hot Flashes
- What is being tested?
- Paroxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteHonduras
- Study dates
- 30 Jan 2025to 1 Sep 2025
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with surgical menopause attending IHSS outpatient clinic.
- Patients with surgical menopause with presence of hot flashes and night sweats.
- Surgical menopausal patients with episodes of anxiety and palpitations.
- Patients with surgical menopause who receive treatment for 6 months with Paroxetine.
- Patients who after reading and explanation of the Informed Consent agree to participate voluntarily.
Who cannot join
- Patients medicated with psychotropic drugs, including all sedatives and hypnotics.
- Patients under treatment with Menopausal Hormone Therapy.
- Patients with impaired hepatic or renal function.
- Patients with unstable heart disease.
- Patients with a history of self-destructive behaviors.
- Patients with a history of clinical diagnosis or treatment for depression or any other psychiatric disorder (including substance abuse or alcohol disorders) and any other ongoing medical condition.
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Instituto Hondureño de Seguridad Social
Tegucigalpa, Francisco Morazán Department, 11101
About this study
Official title: Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause. Randomized Double-blind Clinical Trial
evaluate the efficacy of paroxetine in the management of vasomotor symptoms in patients with surgical menopause, in order to seek an alternative therapy to hormone therapy, which is associated with proinflammatory and procoagulant effects that increase the risk of thrombosis and is therefore contraindicated in people with diabetes mellitus, chronic arterial hypertension and patients with a history of thromboembolism
Read the detailed description
Vasomotor symptoms that occur in the peri-menopausal and postmenopausal period are experienced by 80% of women and can greatly affect the quality of life by temporarily interrupting daily activities. These symptoms are experienced early in our study population who are induced to early menopause by undergoing surgical procedures such as total abdominal hysterectomy plus bilateral salpingo-oophorectomy.
Due to the controversy that exists about the use of hormone replacement therapy, in recent years different alternative therapies have been proposed for the management of these symptoms, mainly for those patients who have contraindications for hormone therapy. For this reason, the use of non-hormonal therapy has been investigated.
Since there are women who have contraindications to conventional therapy such as patients with cardiovascular and thrombosis risks, there is a need to search for new alternative therapies such as selective serotonin reuptake inhibitors, specifically paroxetine, so with our study we seek to evaluate how effective paroxetine is in reducing vasomotor symptoms and thus provide an alternative to this type of patients.
- Conditions
- Menopause Syndrome, Menopause Surgical, Hot Flashes
- Being tested
- Paroxetine, Placebo
- Keywords
- Menopause Syndrome, Menopause Surgical, Hot Flashes, Paroxetine
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParoxetineDrug
20 mg PO daily
PlaceboDietary supplement
Also called Starch
1 capsule starch
| Study group | Role | What they receive |
|---|---|---|
| Paroxetine | Experimental | 20mg Paroxetine once daily for 12 weeks Receives: Drug: Paroxetine |
| Placebo | Placebo comparator | 1 placebo capsule containing starch Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Rating Score (MRS)
change in the Menopause Rating Scale (MRS), which measures 11 variables with a score of 0 to 4, with 0 being the absence of symptoms, scores range from 0 to 44.
Measured: Since intervention until 12 weeks
Secondary outcomes (2)
Frequency of vasomotor symptoms
Changes in the frequency of vasomotor symptoms, The incidence of vasomotor symptoms will be assessed at each visit
Measured: Since intervention until 12 weeks
side effects
incidence of side effects of paroxetine
Measured: Since intervention until 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start30 Jan 2025
- Primary completion31 Jul 2025
- Study completion1 Sep 2025
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 Menopause SyndromeStudies 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
- Model description
- parallel-group, efficacy, superiority, double-blind clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
- Investigators
- Ricardo A. Gutierrez Ramirez, Study director, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763484
- Sponsor's protocol ID
- PGO-UNAH-48-2-2025
- Acronym
- MENOXTINA
- Status last verified
- Sep 2025
- First submitted
- 30 Dec 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not necessary, none of the 18 HIPAA identifiers will be placed
Publications
Iyer TK, Fiffick AN, Batur P. Nonhormone therapies for vasomotor symptom management. Cleve Clin J Med. 2024 Apr 1;91(4):237-244. doi: 10.3949/ccjm.91a.23067.
PubMed 38561208
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause. Randomized Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06763484
- Acronym / sponsor ID
- MENOXTINA / PGO-UNAH-48-2-2025
- Conditions
- Menopause Syndrome, Menopause Surgical, Hot Flashes
- Keywords
- Menopause Syndrome, Menopause Surgical, Hot Flashes, Paroxetine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad Nacional Autonoma de HondurasUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 8 Jan 2025 (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.
evaluate the efficacy of paroxetine in the management of vasomotor symptoms in patients with surgical menopause, in order to seek an alternative therapy to hormone therapy, which is associated with proinflammatory and procoagulant effects that increase the risk of thrombosis and is therefore contraindicated in people with diabetes mellitus, chronic arterial hypertension and patients with a history of thromboembolism
Detailed description
Vasomotor symptoms that occur in the peri-menopausal and postmenopausal period are experienced by 80% of women and can greatly affect the quality of life by temporarily interrupting daily activities. These symptoms are experienced early in our study population who are induced to early menopause by undergoing surgical procedures such as total abdominal hysterectomy plus bilateral salpingo-oophorectomy.
Due to the controversy that exists about the use of hormone replacement therapy, in recent years different alternative therapies have been proposed for the management of these symptoms, mainly for those patients who have contraindications for hormone therapy. For this reason, the use of non-hormonal therapy has been investigated.
Since there are women who have contraindications to conventional therapy such as patients with cardiovascular and thrombosis risks, there is a need to search for new alternative therapies such as selective serotonin reuptake inhibitors, specifically paroxetine, so with our study we seek to evaluate how effective paroxetine is in reducing vasomotor symptoms and thus provide an alternative to this type of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- parallel-group, efficacy, superiority, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Paroxetine | Experimental | Drug: Paroxetine20mg Paroxetine once daily for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 placebo capsule containing starch |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with surgical menopause attending IHSS outpatient clinic.
- Patients with surgical menopause with presence of hot flashes and night sweats.
- Surgical menopausal patients with episodes of anxiety and palpitations.
- Patients with surgical menopause who receive treatment for 6 months with Paroxetine.
- Patients who after reading and explanation of the Informed Consent agree to participate voluntarily.
Key exclusion criteria (6 listed)
- Patients medicated with psychotropic drugs, including all sedatives and hypnotics.
- Patients under treatment with Menopausal Hormone Therapy.
- Patients with impaired hepatic or renal function.
- Patients with unstable heart disease.
- Patients with a history of self-destructive behaviors.
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 |
|---|---|---|
| Paroxetine20 mg PO daily | Drug | Paroxetine |
| PlaceboAlso: Starch1 capsule starch | Dietary supplement | Placebo |
Primary outcome
Menopause Rating Score (MRS)
Time frame: Since intervention until 12 weeks
change in the Menopause Rating Scale (MRS), which measures 11 variables with a score of 0 to 4, with 0 being the absence of symptoms, scores range from 0 to 44.
2 secondary outcomes
Frequency of vasomotor symptoms
Time frame: Since intervention until 12 weeks
side effects
Time frame: Since intervention until 12 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 17 Sep 2025.
- Background: PubMed 38561208Iyer TK, Fiffick AN, Batur P. Nonhormone therapies for vasomotor symptom management. Cleve Clin J Med. 2024 Apr 1;91(4):237-244. doi: 10.3949/ccjm.91a.23067.
- Individual participant dataSharing planned: No. It is not necessary, none of the 18 HIPAA identifiers will be placed
Related trials for Menopause Syndrome
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Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
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Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
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Active, not recruiting
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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.
Ricardo A. Gutierrez Ramirez study director
Universidad Nacional Autonoma de Honduras
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 Paroxetine in people with Menopause Syndrome and Menopause Surgical, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
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 6 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 17 Sep 2025. 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 Honduras. 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?
Menopause Rating Score (MRS) (time frame: Since intervention until 12 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 NCT06763484, 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 17 Sep 2025.