Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-30

Study Completion Date

2025-09-01

Brief Summary

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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

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Detailed Description

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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

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Menopause Syndrome Menopause Surgical Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel-group, efficacy, superiority, double-blind clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

To eliminate researcher bias, a third research participant will place the capsules containing the soy isoflavonate in one bottle and the placebo in another bottle. The bottles will be labeled as group A and group B, but the researchers will not know which is in which group, to ensure that the study intervention and the control/placebo are as indistinguishable as possible to the participants.

Study Groups

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Paroxetine

20mg Paroxetine once daily for 12 weeks

Group Type EXPERIMENTAL

Paroxetine

Intervention Type DRUG

20 mg PO daily

Placebo

1 placebo capsule containing starch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

1 capsule starch

Interventions

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Paroxetine

20 mg PO daily

Intervention Type DRUG

Placebo

1 capsule starch

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Starch

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes