NCT04097288 is a Phase 1 clinical trial of Citalopram 40mg in Stress Urinary Incontinence, sponsored by University Hospital Bispebjerg and Frederiksberg.

Who is sponsoring NCT04097288?

NCT04097288 is sponsored by University Hospital Bispebjerg and Frederiksberg.

What drugs are being tested in NCT04097288?

Interventions in NCT04097288: Citalopram 40mg, Reboxetine 8 mg, Placebo oral tablet, Placebo oral tablet.

What condition does NCT04097288 study?

NCT04097288 studies Stress Urinary Incontinence, Fecal Incontinence.

Is NCT04097288 still recruiting?

NCT04097288 is currently completed. Last updated 9 June 2021.

Last reviewed 2021-06-09 · How we verify

NCT04097288

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

Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects

Completed Phase 1 Last updated 9 June 2021

What this trial tests

Phase 1 trial testing Citalopram 40mg in Stress Urinary Incontinence in 24 participants. Completed in 1 May 2020.

Timeline

17 September 2019

Primary endpoint
1 February 2020

1 May 2020

Quick facts

Lead sponsor	University Hospital Bispebjerg and Frederiksberg
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	24
Start date	17 September 2019
Primary completion	1 February 2020
Estimated completion	1 May 2020
Sites	1 location across Denmark

Drugs / interventions tested

Citalopram 40mg — full drug profile →
Reboxetine 8 mg — full drug profile →
Placebo oral tablet — full drug profile →
Placebo oral tablet — full drug profile →

Conditions studied

Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →
Fecal Incontinence — all drugs for Fecal Incontinence →

Sponsor

University Hospital Bispebjerg and Frederiksberg

Who can join

Adults 18 to 55, female only, with Stress Urinary Incontinence or Fecal Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will investigate if citalopram, a selective serotonin reuptake inhibitor, is reducing the opening pressure of the urethra and possibly causing or worsening stress urinary incontinence. Reboxetine, a norepinephrine reuptake inhibitor, is known to increase urethral opening pressure through actions on adrenoceptors in Onuf´s nucleus and will act as an active control. Furthermore, this study is performed to explore the effects of reboxetine and citalopram on the opening pressure of the anal canal.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of single doses of citalopram and reboxetine on urethral pressure: A randomized, double-blind, placebo- and active-controlled three-period crossover study in healthy women.
Christoffersen T, Kornholt J, Riis T, Sonne J, et al · · 2022 · cited 5× · PMID 35771361 · DOI 10.1002/nau.24985

Verify or expand the search:

Other recruiting trials for Stress Urinary Incontinence

Currently open trials in the same condition.

NCT06706362 — Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study) · Phase 4 · recruiting
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NCT06111209 — The Anabolic Effect of Testosterone on Pelvic Floor Muscles · Phase 2 · recruiting
NCT06731985 — The Follow-up After Shorter Tapes Study. Effectiveness and Safety of Shorter Trans-obturator Tapes. · recruiting

Other University Hospital Bispebjerg and Frederiksberg trials

Trials by the same sponsor.

NCT07060586 — The Effect of Sphenopalatine Ganglion Block on Headache and Vasalgia · NA · completed
NCT06911411 — PALLIATIVE ASSESSMENT COHORT IN THE GERIATRIC EMERGENCY SETTING · not yet recruiting
NCT06405750 — Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate · NA · recruiting
NCT06532825 — Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure · recruiting
NCT06184581 — Lithium Versus Lamotrigine in Bipolar Disorder, Type II · 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 NCT04097288 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital Bispebjerg and Frederiksberg
Last refreshed: 9 June 2021

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/NCT04097288.

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