NCT01975129 is a Phase 2 clinical trial of Vagitocin in Vaginal Atrophy, sponsored by PepTonic Medical AB.

Who is sponsoring NCT01975129?

NCT01975129 is sponsored by PepTonic Medical AB.

What drugs are being tested in NCT01975129?

Interventions in NCT01975129: Vagitocin.

What condition does NCT01975129 study?

NCT01975129 studies Vaginal Atrophy.

Is NCT01975129 still recruiting?

NCT01975129 is currently completed. Last updated 27 May 2015.

Last reviewed 2015-05-27 · How we verify

NCT01975129

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

A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin in Postmenopausal Women With Vaginal Atrophy

Completed Phase 2 Last updated 27 May 2015

What this trial tests

Phase 2 trial testing Vagitocin in Vaginal Atrophy in 12 participants. Completed in 1 February 2014.

Timeline

1 September 2013

Primary endpoint
1 February 2014

1 February 2014

Quick facts

Lead sponsor	PepTonic Medical AB
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 September 2013
Primary completion	1 February 2014
Estimated completion	1 February 2014
Sites	1 location across Sweden

Drugs / interventions tested

Vagitocin — full drug profile →

Conditions studied

Vaginal Atrophy — all drugs for Vaginal Atrophy →

Sponsor

PepTonic Medical AB — full company profile →

Who can join

Adults 40 to 70, female only, with Vaginal Atrophy. Healthy volunteers can join.

What's being measured

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

Oxytocin plasma levels
Time frame: Day 1 to 26
Oxytocin plasma levels after intravaginal and intravenous administration

Sponsor's own description

This study aims to evaluate the uptake of oxytocin following intravaginal administration of Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70 years old with vaginal atrophy will be included and will self-administer Vagitocin intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours, relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic variables will be calculated. The % of oxytocin which was absorbed following vaginal administration (bioavailability)will also be calculated.

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 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

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
NCT04629885 — Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms · Phase 2 · 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 NCT01975129 (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: 27 May 2015

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/NCT01975129.

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