VALOR: Vaginal Atrophy & Long-term Observation of Recovery

NARecruitingINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

October 30, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Atrophic VaginitisVaginal AtrophyGenitourinary Syndrome of MenopauseLichen Sclerosus of VulvaLichen Planus of VulvaLichen Simplex of Vulva (Disorder)
Interventions
DEVICE

7-0940

A non-hormonal and non-steroidal gel that supports vulvovaginal mucosal conditions and speeds up recovery post vaginal rejuvenation. It is a suitable alternative to vaginally administered estrogen and topical corticosteroids, that promotes a moist healing environment leading to faster re-epithelialization. The gel relieves symptoms such as itchiness, tenderness, dryness, burning sensation, painful intercourse (dyspareunia), painful urination (dysuria), rectal and defecating pain. It improves erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain the health of the vaginal mucosa without the side effects of vaginally administered hormonal therapy and topical corticosteroids.

Trial Locations (12)

28303

RECRUITING

WR-Carolina Institute for Clinical Research, Fayetteville

29169

RECRUITING

Southern Urogynecology, West Columbia

29414

NOT_YET_RECRUITING

WR-Charleston Clinical Trials, LLC, Charleston

30328

NOT_YET_RECRUITING

WR-Mount Vernon Clinical Research, LLC, Sandy Springs

32055

NOT_YET_RECRUITING

WR-Multi-Specialty Research Associates, Lake City

38210

NOT_YET_RECRUITING

WR-Medical Research Center of Memphis, LLC, Memphis

75224

RECRUITING

WR-Global Medical Research, LLC, Dallas

89106

NOT_YET_RECRUITING

WR-Clinical Research Center of Nevada, LLC, Las Vegas

90720

NOT_YET_RECRUITING

WR-PRI, LLC (Los Alamitos), Los Alamitos

92111

NOT_YET_RECRUITING

WR-Women's Health Care Research, LLC, San Diego

92653

ACTIVE_NOT_RECRUITING

Orange Coast Women's Medical Group, Laguna Hills

92660

RECRUITING

WR-PRI, LLC (Newport Beach), Newport Beach

All Listed Sponsors
lead

Stratpharma AG

INDUSTRY