Clinical trial NCT04887701: Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
Official title: Clinical Outcomes and Safety of a Non-hormonal Medical Device Versus a Sham Device on the Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women Who Have Failed, Refused, or Are Contraindicated for Hormone Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Atrophy
Lead sponsor: Madorra
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 25
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinician Assessed Changes in VVA
timeFrame: Baseline to 12 weeks
measure: Patient Reported VAS Score
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Responder Rate PGI-I
timeFrame: 12 weeks
Other outcomes:
measure: Incidence of Adverse Events
timeFrame: 1 year
measure: Patient Satisfaction with Treatment: Likert Scale
timeFrame: 6 months and 1 year
Locations:
city: Sydney
country: Australia
facility: North Shore Private Hospital
state: New South Wales
city: Bendigo
country: Australia
facility: Goldfields Urology
state: Victoria
city: Melbourne
country: Australia
facility: Royal Women's Hospital
state: Victoria
Study officials:
affiliation: North Shore Private Hospital
name: Rodney Baber, MD
role: PRINCIPAL_INVESTIGATOR
References: