Erectile DysfunctionNCT04179747
Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
A study testing Cognitive Behavioral Psychotherapy and Sildenafil Citrate 50Mg Tab in people with Erectile Dysfunction, run by International Islamic University, Islamabad at 1 site in Pakistan.
Trial summary
The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with two arms involving a control group. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Cognitive Behavioral Psychotherapy and Sildenafil Citrate 50Mg Tab
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jan 2018to 24 Jul 2018
- Phase
- Interventional
- 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 39 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men diagnosed with erectile dysfunction
- Must be in the age range of 18 to 39 years
- Must be in a stable heterosexual relationship
- Must not be suffering from any medical or psychiatric illness
Who cannot join
- Men not meeting criteria of diagnosis of erectile dysfunction
- Men not in a heterosexual relationship
- Men of or above the age of 40 years
- Men diagnosed with any medical or psychiatric illness or obese men
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ahmad Bilal Private Practice
Chak Eighty-seven -Twelve Left, South Punjab, 63100
About this study
Official title: A Comparison of Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with two arms involving a control group. The study was conducted with an aim of pilot and feasibility study to evaluate the efficacy and suitability of cognitive behavior psychotherapy with individuals suffering from erectile dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- Cognitive Behavioral Psychotherapy, Sildenafil Citrate 50Mg Tab
- Keywords
- Sexual Dysfunctions, Men Health
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral PsychotherapyBehavioural
Also called Cognitive Behavior Psychotherapy
The Cognitive Behavior Psychotherapy was provided for a period of maximum 3 months.
Sildenafil Citrate 50Mg TabDrug
Also called PDE5i
The participants in control group arm received Sildenafil Citrate 50mg tablet on demand for a period of maximum 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The cognitive behavior psychotherapy was administered to participants in this treatment arm. Receives: Behavioral: Cognitive Behavioral Psychotherapy |
| Control Group | Active comparator | This group received the administration of pharmacotherapy (PDE5i) for treatment of Erectile Dysfunction. Receives: Drug: Sildenafil Citrate 50Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Functioning-5
The minimum scale score is 5. The maximum scale score is 25. The higher score indicates better erectile functioning.
Measured: 3 months maximum
Secondary outcomes (1)
Depression, Anxiety, and Stress Scale-21
The scale has three sub-scales.
- Depression sub scale, Minimum Score: Zero; Maximum Score: 42
- Anxiety sub scale, Minimum Score: Zero; Maximum Score: 42
- Stress sub scale, Minimum Score: Zero; Maximum Score: 42 The lowest scores on each of the sub scales indicate better functioning, the higher scores on each sub scale indicate a worse outcome.
Measured: 3 months maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start18 Jan 2018
- Primary completion24 Jul 2018
- Study completion24 Jul 2018
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 Erectile DysfunctionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Islamic University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Bilal, International Islamic University, Islamabad
- Investigators
- Ahmad Bilal, MPhil, Principal investigator, International Islamic University, Islamabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179747
- Sponsor's protocol ID
- 0925-0585
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bilal A, Abbasi NUH. Development of an indigenous manual of cognitive behavior sex therapy for young men. J Family Med Prim Care. 2022 Aug;11(8):4127-4130. doi: 10.4103/jfmpc.jfmpc_1892_21. Epub 2022 Aug 30.
PubMed 36353027
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
- ClinicalTrials.gov ID
- NCT04179747
- Acronym / sponsor ID
- 0925-0585
- Conditions
- Erectile Dysfunction
- Keywords
- Sexual Dysfunctions, Men Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- International Islamic University, IslamabadUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 27 Nov 2019 (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 study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with two arms involving a control group. The study was conducted with an aim of pilot and feasibility study to evaluate the efficacy and suitability of cognitive behavior psychotherapy with individuals suffering from erectile dysfunction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Cognitive Behavioral PsychotherapyThe cognitive behavior psychotherapy was administered to participants in this treatment arm. |
| Control Group | Active comparator | Drug: Sildenafil Citrate 50Mg TabThis group received the administration of pharmacotherapy (PDE5i) for treatment of Erectile Dysfunction. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men diagnosed with erectile dysfunction
- Must be in the age range of 18 to 39 years
- Must be in a stable heterosexual relationship
- Must not be suffering from any medical or psychiatric illness
Key exclusion criteria (4 listed)
- Men not meeting criteria of diagnosis of erectile dysfunction
- Men not in a heterosexual relationship
- Men of or above the age of 40 years
- Men diagnosed with any medical or psychiatric illness or obese men
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 |
|---|---|---|
| Cognitive Behavioral PsychotherapyAlso: Cognitive Behavior PsychotherapyThe Cognitive Behavior Psychotherapy was provided for a period of maximum 3 months. | Behavioural | Group A |
| Sildenafil Citrate 50Mg TabAlso: PDE5iThe participants in control group arm received Sildenafil Citrate 50mg tablet on demand for a period of maximum 3 months. | Drug | Control Group |
Primary outcome
International Index of Erectile Functioning-5
Time frame: 3 months maximum
The minimum scale score is 5. The maximum scale score is 25. The higher score indicates better erectile functioning.
1 secondary outcome
Depression, Anxiety, and Stress Scale-21
Time frame: 3 months maximum
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 29 Nov 2019.
- Derived from this study: PubMed 36353027Bilal A, Abbasi NUH. Development of an indigenous manual of cognitive behavior sex therapy for young men. J Family Med Prim Care. 2022 Aug;11(8):4127-4130. doi: 10.4103/jfmpc.jfmpc_1892_21. Epub 2022 Aug 30.
- Individual participant dataSharing planned: No
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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.
Ahmad Bilal, MPhil principal investigator
International Islamic University, Islamabad, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Psychotherapy and Sildenafil Citrate 50Mg Tab in people with Erectile Dysfunction, run by International Islamic University, Islamabad at 1 site in Pakistan.
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 4 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 29 Nov 2019. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
International Index of Erectile Functioning-5 (time frame: 3 months maximum). 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 NCT04179747, 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 29 Nov 2019.