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

Madorra

Status

Completed

Conditions

Vulvovaginal Atrophy

Treatments

Device: Sham vaginal device therapy

Device: Non-hormonal vaginal device therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT04887701

CLN-201

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

Female

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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.