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

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg
• Treatments: Citalopram; Dexetimide; Reboxetine

Criteria

Inclusion Criteria:

• Signed written consent of participation

• Female

• Age between 18 and 55 years (both included)

• Normal weight (BMI 18,5 to 30,0 kg/m2).

• Regular use of safe contraceptive products ie. Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long acting injections) through the entire trial and until eight days after the study has ended for the subject (registered at trial day one, two and three). Subjects who are postmenopausal (defined as no menses for 12 months or more prior enrolment) can be included without use of contraceptive products.

Exclusion Criteria:

• Known hypersensitivity of Citalopram.

• Known hypersensitivity of Edronax.

• A history of significant cardiovascular, gastrointestinal, endocrine, hematologic, immunologic, metabolic or genitourologic disease (including pelvic surgery because of trauma, pelvic trauma, lower urinary tract surgery, irradiation to the pelvis, history or evidence of an anatomical anomaly of the lower urinary tract, urinary outlet obstruction, urinary retention, urethral hypermobility , prolapse of pelvic organs, hematuria or urinary tract infection at screening) or lung disease, neurologic, dermatologic, psychiatric disease, kidney disease, malign diseases or other major diseases assessed by the investigator.

• Known QT-interval prolongation or congenital long QT syndrome

• History or objective symptoms of urinary incontinence

• Current infectious disease (fever and symptoms associated with viral or bacterial disease (including respiratory tract infections) or fungal disease (excluding cutaneous infection).

• Pulse under 40 beats pr. minute or above 100 beats pr. minute. Average systolic blood pressure above 140 mmHg or average diastolic blood pressure over 90 mmHg (average of three measurements performed on screening). In case blood pressure or pulse should deviate from these criteria allowance of three additional measurements are accepted.

• Current participation in other clinical trials that might affect the results of this trial (judged by the investigators).

• Use of prescription drugs, over the-counter drugs or herbalism drugs. Exceptions from these criteria are use of paracetamol (4 g a day) and safe contraception as stated above.

• Current consumption of alcohol above 14 units of alcohol a week.

• Smoking within three months.

• Drug abuse within three months.

• Present pregnancy, at screening or during the trial, including a positive pregnancy test (presented at trial day one, two or three).

• Breastfeeding at screening or during the study (registered at trial day one, two and three).

• Any kind of condition (anamnestic or objective) that the investigator assess that must lead to exclusion of this study.