Urinary Incontinence,StressPhase 1NCT05095077
Effects of Single Dose Tadalafil on Urethral and Anal Closure Function
A Phase 1 study testing Tadalafil 40 MG in people with Urinary Incontinence,Stress and Fecal Incontinence, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive comparator) on the urethral - and anal pressure and on urine flow in healthy females. Further, the purpose of the trial is to evaluate the potential for going forward with studies of tadalafil in patients suffering from urine… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence,Stress, Fecal Incontinence
- What is being tested?
- Tadalafil 40 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2021to 1 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent form
- Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
- Sexual abstinence or use of safe contraceptive methods i.e. intrauterine devices, hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long acting injections), or surgically sterilized partner throughout the course of the study and until six days after the study has ended for the subject. Women who are postmenopausal (defined as no menstrual periods for 12 months or more prior to enrolment) can be included without use of contraceptive methods.
- Presentation of a negative urine human chorionic gonadotropin (hCG) urine pregnancy test prior to dosing (on both study days)
Who cannot join
- History of clinically significant urinary incontinence.
- Current acute or chronic condition, unless considered clinically irrelevant and stable by the investigator.
- Average systolic blood pressure <100 mmHg or >140 mmHg and/or average diastolic blood pressure <60 mmHg or >90 mmHg (average of three measurements performed at screening).
- Average pulse < 40 or > 100 beats/minute (average of three measurements performed at screening).
- Pregnancy within 6 months before screening and throughout the study period.
- Breastfeeding throughout the study period and 6 days after study day 2.
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- Any systemic drug use within 2 weeks before first study drug administration (prescription drugs, over-the-counter drugs, herbal drugs and illicit drugs), except for occasional use of paracetamol (up to 4 g/day), hormonal contraceptives and hormone replacement therapy.
- Smoking or other regular use of any form of nicotine product during the study period and the previous 3 months.
- Alcohol consume 24 hours prior to dosing.
- Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Single Dose Tadalafil on Urethral and Anal Closure Function and on Urinary Flow in Healthy Females: A Randomised, Controlled, Double-blinded, Two-period Cross-over Study
The purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive comparator) on the urethral - and anal pressure and on urine flow in healthy females. Further, the purpose of the trial is to evaluate the potential for going forward with studies of tadalafil in patients suffering from urine or fecal incontinence.
- Conditions
- Urinary Incontinence,Stress, Fecal Incontinence
- Being tested
- Tadalafil 40 MG, Placebo
- Medical subject headings
- Urinary Incontinence, Stress, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 40 MGDrug
Single dose on study day 1/2
PlaceboDrug
Identical to active IMP
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil | Experimental | Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2. Receives: Drug: Tadalafil 40 MG |
| Placebo | Placebo comparator | Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected change in opening urethral pressure after single dose tadalafil
Difference in average urethral opening pressure (UOP) after administration of 40 mg tadalafil (UOP-tadalafil) compared to UOP after placebo (during relaxation).
Measured: 2 hours post-dose
Secondary outcomes (5)
Difference in average anal opening pressure (AOP) after administration of 40 mg tadalafil compared to AOP after placebo (during relaxation).
Difference in average anal opening pressure (AOP) after administration of 40 mg tadalafil compared to AOP after placebo (during relaxation).
Measured: 2-hours post-dose
Difference in average UOP-tadalafil and average UOP-placebo during squeezing.
Measured: 2-hours post-dose
Difference in average AOP-tadalafil and average AOP-placebo during squeezing.
Measured: 2-hours post-dose
Elastance (opening/closing) during relaxation and squeezing (tadalafil compared to placebo).
Measured: 2-hours post-dose
Difference in maximum urine flow rate (Qmax) and average urine flow rate (Qave) after tadalafil and placebo administration, respectively.
Measured: 2-hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Aug 2021
- Primary completion30 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-period (AB/BA) crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thea Christoffersen, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Thea Christoffersen, Principal investigator, Zelo Phase 1 unit, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095077
- Sponsor's protocol ID
- PDE5I-UPR-AAR-01
- Other IDs
- 2020-005839-76
- Status last verified
- Apr 2022
- First submitted
- 26 Aug 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Christoffersen T, Riis T, Sonne DP, Klarskov N. Single-dose Tadalafil Reduces Opening Urethral Pressure: A Randomized, Double-blind, Placebo-controlled, Crossover Trial in Healthy Women. Int Urogynecol J. 2024 Mar;35(3):723-729. doi: 10.1007/s00192-024-05757-9. Epub 2024 Mar 8.
PubMed 38456894
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Single Dose Tadalafil on Urethral and Anal Closure Function and on Urinary Flow in Healthy Females: A Randomised, Controlled, Double-blinded, Two-period Cross-over Study
- ClinicalTrials.gov ID
- NCT05095077
- Acronym / sponsor ID
- PDE5I-UPR-AAR-01
- Conditions
- Urinary Incontinence,Stress, Fecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive comparator) on the urethral - and anal pressure and on urine flow in healthy females. Further, the purpose of the trial is to evaluate the potential for going forward with studies of tadalafil in patients suffering from urine or fecal incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-period (AB/BA) crossover study
| Arm | Type | Receives |
|---|---|---|
| Tadalafil | Experimental | Drug: Tadalafil 40 MGSubjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent form
- Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
- Sexual abstinence or use of safe contraceptive methods i.e. intrauterine devices, hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long acting injections), or surgically sterilized partner throughout the course of the study and until six days after the study has ended for the subject. Women who are postmenopausal (defined as no menstrual periods for 12 months or more prior to enrolment) can be included without use of contraceptive methods.
- Presentation of a negative urine human chorionic gonadotropin (hCG) urine pregnancy test prior to dosing (on both study days)
Key exclusion criteria (10 listed)
- History of clinically significant urinary incontinence.
- Current acute or chronic condition, unless considered clinically irrelevant and stable by the investigator.
- Average systolic blood pressure <100 mmHg or >140 mmHg and/or average diastolic blood pressure <60 mmHg or >90 mmHg (average of three measurements performed at screening).
- Average pulse < 40 or > 100 beats/minute (average of three measurements performed at screening).
- Pregnancy within 6 months before screening and throughout the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tadalafil 40 MGSingle dose on study day 1/2 | Drug | Tadalafil |
| PlaceboIdentical to active IMP | Drug | Placebo |
Primary outcome
Placebo-corrected change in opening urethral pressure after single dose tadalafil
Time frame: 2 hours post-dose
Difference in average urethral opening pressure (UOP) after administration of 40 mg tadalafil (UOP-tadalafil) compared to UOP after placebo (during relaxation).
5 secondary outcomes
Difference in average anal opening pressure (AOP) after administration of 40 mg tadalafil compared to AOP after placebo (during relaxation).
Time frame: 2-hours post-dose
Difference in average UOP-tadalafil and average UOP-placebo during squeezing.
Time frame: 2-hours post-dose
Difference in average AOP-tadalafil and average AOP-placebo during squeezing.
Time frame: 2-hours post-dose
Elastance (opening/closing) during relaxation and squeezing (tadalafil compared to placebo).
Time frame: 2-hours post-dose
Difference in maximum urine flow rate (Qmax) and average urine flow rate (Qave) after tadalafil and placebo administration, respectively.
Time frame: 2-hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 38456894Christoffersen T, Riis T, Sonne DP, Klarskov N. Single-dose Tadalafil Reduces Opening Urethral Pressure: A Randomized, Double-blind, Placebo-controlled, Crossover Trial in Healthy Women. Int Urogynecol J. 2024 Mar;35(3):723-729. doi: 10.1007/s00192-024-05757-9. Epub 2024 Mar 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thea Christoffersen principal investigator
Zelo Phase 1 unit, University Hospital Bispebjerg and Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tadalafil 40 MG in people with Urinary Incontinence,Stress and Fecal Incontinence, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo-corrected change in opening urethral pressure after single dose tadalafil (time frame: 2 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.