NCT06514586 is a Phase 3 clinical trial of Oxytocin in Vaginal Atrophy, sponsored by Oxagon.

Who is sponsoring NCT06514586?

NCT06514586 is sponsored by Oxagon.

What drugs are being tested in NCT06514586?

Interventions in NCT06514586: Oxytocin, Hydroxypropyl methylcellulose.

What condition does NCT06514586 study?

NCT06514586 studies Vaginal Atrophy, Genitourinary Syndrome of Menopause, Vulvar Atrophy.

Is NCT06514586 still recruiting?

NCT06514586 is currently not yet recruiting. Last updated 17 July 2024.

Last reviewed 2024-07-17 · How we verify

NCT06514586

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vuluvovaginal Atrophy: A Randomized Controlled Trial

Not yet recruiting Phase 3 Last updated 17 July 2024

What this trial tests

Phase 3 trial testing Oxytocin in Vaginal Atrophy in 244 participants. Not yet recruiting.

Timeline

1 September 2024

Primary endpoint
1 June 2025

1 August 2025

Quick facts

Lead sponsor	Oxagon
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	244
Start date	1 September 2024
Primary completion	1 June 2025
Estimated completion	1 August 2025
Sites	1 location across Egypt

Drugs / interventions tested

Oxytocin (OXYTOCIN) — full drug profile →
Hydroxypropyl methylcellulose — full drug profile →

Conditions studied

Vaginal Atrophy — all drugs for Vaginal Atrophy →
Genitourinary Syndrome of Menopause — all drugs for Genitourinary Syndrome of Menopause →
Vulvar Atrophy — all drugs for Vulvar Atrophy →

Sponsor

Oxagon

Who can join

Adults 47 to 65, female only, with Vaginal Atrophy or Genitourinary Syndrome of Menopause. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The mean change from the baseline to Day 60 of the severity of the Most Bothersome Symptom (MBS) self-assessment.
Time frame: 60 days
MBS is a moderate to severe symptom identified as the most bothersome by the subject at baseline, recorded as none, mild, moderate, or severe was analyzed using the score values of 0, 1, 2, or 3, respectively. Symptoms include vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain (dyspareunia), or bleeding associated with sexual activity.
The mean change from the baseline to Day 60 of the vaginal pH
Time frame: 60 days
Vaginal pH as measured by a pH strip applied directly to the lateral wall of the vagina, recording the pH value (to one decimal) according to the comparison to the color chart.
The mean change from the baseline to Day 60 of the Vaginal Maturation Index (VMI)
Time frame: 60 days
VMI is calculated using the Meisels'(Meisels, 1967) formula: (0 \* Parabasal Cells) + (0.5 \* Intermediate Cells) + (1 \* Superficial Cells).

Sponsor's own description

A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Oxytocin

Trials testing the same drug.

NCT07401524 — Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage · Phase 4 · not yet recruiting
NCT07188207 — Rectal Misoprostol for Reducing Blood Loss in Elective Cesarean Section · NA · not yet recruiting
NCT06968481 — Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage · Phase 2 · not yet recruiting
NCT07265180 — Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison · NA · recruiting
NCT07119398 — Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM · Phase 4 · recruiting

Other recruiting trials for Vaginal Atrophy

Currently open trials in the same condition.

NCT05457972 — Postpartum Vaginal Estrogen for Breastfeeding Patients · Phase 4 · recruiting
NCT06028009 — PRP Injections for Genitourinary Syndrome of Menopause · NA · active not recruiting
NCT07024667 — Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vagin · NA · recruiting
NCT05335317 — Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser · NA · recruiting
NCT04807894 — Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06514586 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oxagon
Last refreshed: 17 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06514586.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing