Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women

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

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-09

Study Completion Date

2022-08-22

Brief Summary

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Randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness and safety of non-hormonal medical device versus sham device to treat VVA in post-menopausal women.

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Detailed Description

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After screening and baseline assessment, participants, ages 21 to 65 years of age, will be randomized and followed for a 12-week intervention period. After the primary endpoint evaluation at week 12, each participant in both arms will immediately commence an open label period using an Active device for week 13 to 1 year to collect further effectiveness and safety data.

Conditions

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Vulvovaginal Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Non-hormonal device therapy

Daily non-hormonal device therapy

Group Type EXPERIMENTAL

Non-hormonal vaginal device therapy

Intervention Type DEVICE

Experimental Active Therapy

Sham Therapy

Daily non-hormonal sham device therapy

Group Type SHAM_COMPARATOR

Sham vaginal device therapy

Intervention Type DEVICE

Sham Comparator

Interventions

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Non-hormonal vaginal device therapy

Experimental Active Therapy

Intervention Type DEVICE

Sham vaginal device therapy

Sham Comparator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women with menopause defined by last menstrual period at least 12 months prior to screening, or 6 months of amenorrhea with serum FSH levels \> 40 mIU/ml, or 8 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
* Sexually active women.
* Participant experiencing subjective moderate-to-severe vaginal pain with sexual intercourse.
* Participant experiencing subjective moderate-to-severe vaginal dryness.
* Gynecological exam confirming vaginal atrophy.
* Willingness to give voluntary written informed consent to participate in the study and comply with protocol requirements.

Exclusion Criteria

* Use of systemic or local estrogen therapy, currently or in the last 6 months or planned use during the study.
* Use of any other treatment for vaginal atrophy, 6 weeks prior to enrollment or planned during the study period.
* Investigational drugs and also prescription and nonprescription medications/remedies known to treat VVA within 60 days of enrollment or during the study.
* Vaginal stenosis.
* Pelvic floor disorders.
* Prior pelvic radiation therapy including radiation or surgery to the vulva/vagina.
* Active urinary tract, yeast, or other active gynecologic infections.
* Active connective tissue disorders such as lupus or Sjogren's syndrome.
* Active malignancies.
* Diagnosis of vulvodynia or other pelvic pain in the vagina or vulvar area.
* Vulvar dermatoses.
* Laser or radio frequency vaginal rejuvenation treatment or planned treatment during the study.
* Any medical condition that, in the investigator's opinion, would interfere with their participation and/or completion in the study.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No