Erectile DysfunctionNCT04126252
Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction
A study testing Sildenafil Citrate 50Mg Tab, Cognitive Behavioral Psychotherapy and Combined or Integrated Therapy 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 four arms involving a control group. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Sildenafil Citrate 50Mg Tab, Cognitive Behavioral Psychotherapy and Combined or Integrated Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Aug 2018to 3 Sep 2019
- 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 40 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 40 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 above the age of 40 years
- Men diagnosed with any medical or psychiatric illness
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ahmad Bilal Private Practice
Chak Eighty-seven -Twelve Left, Punjab Province, 63100
About this study
Official title: A Comparison of Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction
The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with four arms involving a control group.
- Conditions
- Erectile Dysfunction
- Being tested
- Sildenafil Citrate 50Mg Tab, Cognitive Behavioral Psychotherapy, Combined or Integrated Therapy, Placebo
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil Citrate 50Mg TabDrug
The Group A received sildenafil citrate 50 mg on demand for a period of max 3 months.
Cognitive Behavioral PsychotherapyBehavioural
The Group B received cognitive behavior psychotherapy for a period of max 3 months.
Combined or Integrated TherapyCombination product
The Group C received the combined therapeutic approach for a period of max 3 months.
PlaceboOther
The Group D received no treatment or placebo for a period of max 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | This arm received pharmacotherapy for erectile dysfunction. Receives: Drug: Sildenafil Citrate 50Mg Tab |
| Group B | Experimental | This arm received cognitive behavior psychotherapy for erectile dysfunction. Receives: Behavioral: Cognitive Behavioral Psychotherapy |
| Group C | Experimental | This arm received combined treatment approach. Receives: Combination Product: Combined or Integrated Therapy |
| Group D | Placebo comparator | This arm acted as a control group and received placebo or no intervention. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Functioning-5
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 posted15 Oct 2019
- Study start29 Aug 2018
- Primary completion3 Sep 2019
- Study completion3 Sep 2019
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
- 116 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, Principal investigator, International Islamic University, Islamabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126252
- Sponsor's protocol ID
- 0925-0586
- Status last verified
- Nov 2019
- First submitted
- 11 Oct 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT04126252
- Acronym / sponsor ID
- 0925-0586
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- International Islamic University, IslamabadUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 15 Oct 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 four arms involving a control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Sildenafil Citrate 50Mg TabThis arm received pharmacotherapy for erectile dysfunction. |
| Group B | Experimental | Behavioral: Cognitive Behavioral PsychotherapyThis arm received cognitive behavior psychotherapy for erectile dysfunction. |
| Group C | Experimental | Combination Product: Combined or Integrated TherapyThis arm received combined treatment approach. |
| Group D | Placebo comparator | Other: PlaceboThis arm acted as a control group and received placebo or no intervention. |
Who may qualify
- Ages
- 18 to 40 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 40 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 above the age of 40 years
- Men diagnosed with any medical or psychiatric illness
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 |
|---|---|---|
| Sildenafil Citrate 50Mg TabThe Group A received sildenafil citrate 50 mg on demand for a period of max 3 months. | Drug | Group A |
| Cognitive Behavioral PsychotherapyThe Group B received cognitive behavior psychotherapy for a period of max 3 months. | Behavioural | Group B |
| Combined or Integrated TherapyThe Group C received the combined therapeutic approach for a period of max 3 months. | Combination product | Group C |
| PlaceboThe Group D received no treatment or placebo for a period of max 3 months. | Other | Group D |
Primary outcome
International Index of Erectile Functioning-5
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 2 Dec 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.
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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 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 Sildenafil Citrate 50Mg Tab, Cognitive Behavioral Psychotherapy and Combined or Integrated Therapy 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 2 Dec 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. 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.
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 NCT04126252, 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 2 Dec 2019.