NCT04629885 is a Phase 2 clinical trial of Oxytocin 400 IU vaginal gel in Vulvovaginal Atrophy, sponsored by PepTonic Medical AB.

Who is sponsoring NCT04629885?

NCT04629885 is sponsored by PepTonic Medical AB.

What drugs are being tested in NCT04629885?

Interventions in NCT04629885: Oxytocin 400 IU vaginal gel, Placebo.

What condition does NCT04629885 study?

NCT04629885 studies Vulvovaginal Atrophy.

Is NCT04629885 still recruiting?

NCT04629885 is currently completed. Last updated 16 November 2020.

Last reviewed 2020-11-16 · How we verify

NCT04629885

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

Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms

Completed Phase 2 Last updated 16 November 2020

What this trial tests

Phase 2 trial testing Oxytocin 400 IU vaginal gel in Vulvovaginal Atrophy in 202 participants. Completed in 3 May 2017.

Timeline

3 May 2016

Primary endpoint
3 May 2017

3 May 2017

Quick facts

Lead sponsor	PepTonic Medical AB
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	202
Start date	3 May 2016
Primary completion	3 May 2017
Estimated completion	3 May 2017
Sites	3 locations across Sweden

Drugs / interventions tested

Oxytocin 400 IU vaginal gel — full drug profile →
Placebo

Conditions studied

Vulvovaginal Atrophy — all drugs for Vulvovaginal Atrophy →

Sponsor

PepTonic Medical AB — full company profile →

Who can join

Adults 40 to 65, female only, with Vulvovaginal Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized, double-blind, placebo controlled Phase 2b study, divided in 2 parts: * The main part of the study investigates the efficacy and safety of the Investigational Medicinal Product (IMP), intravaginally administered in glass syringes, on postmenopausal women with vulvovaginal atrophy symptoms. * The exploratory part of the study investigates the efficacy and safety of the IMP, intravaginally administered in a laminate tube, on postmenopausal women with vulvovaginal atrophy symptoms. A comparison of plasma levels of oxytocin when the IMP is administered by 2 different applicators will be investigated in a sub-group of patients. In the main part, 160 subjects are enrolled and randomized to 2 different groups; 80 subjects receiving IMP and 80 subjects receiving placebo, in glass syringes. In the exploratory part of the study, 40 patients will be enrolled and randomized to 2 different groups; 30 subjects receiving IMP and 10 patients receiving placebo, in laminate tubes. The study is conducted at 3 sites in Sweden, and comprises 5 visits: screening visit (Visit 0), randomization visit (Visit 1; Day 0), treatment follow-up visit (Visit 2; Week 4), end of treatment visit (Visit 3; Week 12) and a telephone follow-up visit (Visit 4; Week 14). All patients self-administer the IMP once daily for 12 weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Vulvovaginal Atrophy

Currently open trials in the same condition.

NCT05562518 — GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therap · Phase 4 · active not recruiting

Other PepTonic Medical AB trials

Trials by the same sponsor.

NCT06104098 — A User Study With Vernivia® for Bacterial Vaginosis. · NA · completed
NCT04489290 — Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis · NA · unknown
NCT03998722 — Evaluation of VagiVital® for Treatment of Vaginal Atrophy · NA · completed

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 NCT04629885 (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 PepTonic Medical AB
Last refreshed: 16 November 2020

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/NCT04629885.

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