Sexual DysfunctionPhase 4NCT00923676
Treatment of Hyperlipidemia and Sexual Dysfunction
A Phase 4 study testing fenofibrate, Rosuvastatin and fenofibrate + rosuvastatin in people with Sexual Dysfunction and Hyperlipidemia, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Hyperlipidemias are frequently associated with and are considered an important cause of erectile dysfunction in men. This association has been attributed to the impairment of blood flow through endothelium-dependent relaxation in smooth muscle cells of corpus cavernosum. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction, Hyperlipidemia
- What is being tested?
- fenofibrate, Rosuvastatin and fenofibrate + rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2008to Apr 2016
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low-density lipoprotein (LDL)-cholesterol levels > 160 mg/dL, high-density lipoprotein (HDL)-cholesterol levels < 50 mg/dL (for women) and < 40 mg/dl (for men), or triglyceride levels > 150 mg/dL.
- Stable heterosexual partner relationship for the preceding 6 months.
Who cannot join
- Pregnancy or less than 8 weeks postpartum.
- Diabetes mellitus (fasting glucose > 126 mg/dl.
- Uremia.
- Multiple sclerosis.
- Chronic alcoholism (intake of ≥ 500g/wk).
- Cancer.
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- Psychiatric problems.
- Symptomatic cardiovascular disease.
- Gynecological surgery.
- Pelvic trauma.
- Polycystic ovarian syndrome.
- Abnormal thyroid function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Fenofibrate and Rosuvastatin on Sexual Dysfunction in Hyperlipidemic Patients. A Randomized Trial
Hyperlipidemias are frequently associated with and are considered an important cause of erectile dysfunction in men. This association has been attributed to the impairment of blood flow through endothelium-dependent relaxation in smooth muscle cells of corpus cavernosum. Basic science and human research suggest that the vascular pathophysiology of male and female sexual dysfunction may be similar, as the first phase of the female sexual response is mediated by a combination of vasocongestive and neuro-muscular event which include increased clitoral length and diameter, as well as increased vaginal lubrication, wall engorgement and luminal diameter. The investigators have shown that women with hyperlipidemia had a higher prevalence of sexual dysfunction as compared with age-matched women without hyperlipidemia.
The aim of this study was to asses the effect of anti-hyperlipidemic drugs (fenofibrate and rosuvastatin, single or in combination) on validated indices of sexual function in hyperlipidemic men and women with sexual dysfunction at baseline.
- Conditions
- Sexual Dysfunction, Hyperlipidemia
- Being tested
- fenofibrate, Rosuvastatin, fenofibrate + rosuvastatin
- Keywords
- Hyperlipidemia, LDL-cholesterol, HDL-cholesterol, triglycerides, IIEF, FSFI, Male and female sexual dysfunctions
- Medical subject headings
- Sexual Dysfunction, Physiological, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenofibrateDrug
pill 145 mg, 145 mg/day, for 12 months
RosuvastatinDrug
pills of 10 mg, 10 mg/day, 12 months
fenofibrate + rosuvastatinDrug
fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate | Active comparator | Fenofibrate pills Receives: Drug: fenofibrate |
| Rosuvastatin | Active comparator | Rosuvastatin pills Receives: Drug: Rosuvastatin |
| fenofibrate + rosuvastatin | Active comparator | fenofibrate pills + rosuvastatin pills Receives: Drug: fenofibrate + rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women
Measured: Baseline, 6 months, 12 months
Secondary outcomes (1)
Blood lipids, inflammatory markers
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionOct 2015
- Study completionApr 2016 (estimated)
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 Sexual 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Giugliano, University of Campania Luigi Vanvitelli
- Investigators
- Dario Giugliano, MD,PhD, Principal investigator, Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923676
- Sponsor's protocol ID
- DGMM/03/2007
- Status last verified
- Nov 2015
- First submitted
- 15 Jun 2009
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Esposito K, Ciotola M, Maiorino MI, Giugliano F, Autorino R, De Sio M, Cozzolino D, Saccomanno F, Giugliano D. Hyperlipidemia and sexual function in premenopausal women. J Sex Med. 2009 Jun;6(6):1696-1703. doi: 10.1111/j.1743-6109.2009.01284.x. Epub 2009 Apr 23.
PubMed 19453904
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fenofibrate and Rosuvastatin on Sexual Dysfunction in Hyperlipidemic Patients. A Randomized Trial
- ClinicalTrials.gov ID
- NCT00923676
- Acronym / sponsor ID
- DGMM/03/2007
- Conditions
- Sexual Dysfunction, Hyperlipidemia
- Keywords
- Hyperlipidemia, LDL-cholesterol, HDL-cholesterol, triglycerides, IIEF, FSFI, Male and female sexual dysfunctions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 18 Jun 2009 (estimated)
- 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.
Hyperlipidemias are frequently associated with and are considered an important cause of erectile dysfunction in men. This association has been attributed to the impairment of blood flow through endothelium-dependent relaxation in smooth muscle cells of corpus cavernosum. Basic science and human research suggest that the vascular pathophysiology of male and female sexual dysfunction may be similar, as the first phase of the female sexual response is mediated by a combination of vasocongestive and neuro-muscular event which include increased clitoral length and diameter, as well as increased vaginal lubrication, wall engorgement and luminal diameter. The investigators have shown that women with hyperlipidemia had a higher prevalence of sexual dysfunction as compared with age-matched women without hyperlipidemia.
The aim of this study was to asses the effect of anti-hyperlipidemic drugs (fenofibrate and rosuvastatin, single or in combination) on validated indices of sexual function in hyperlipidemic men and women with sexual dysfunction at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate | Active comparator | Drug: fenofibrateFenofibrate pills |
| Rosuvastatin | Active comparator | Drug: RosuvastatinRosuvastatin pills |
| fenofibrate + rosuvastatin | Active comparator | Drug: fenofibrate + rosuvastatinfenofibrate pills + rosuvastatin pills |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low-density lipoprotein (LDL)-cholesterol levels > 160 mg/dL, high-density lipoprotein (HDL)-cholesterol levels < 50 mg/dL (for women) and < 40 mg/dl (for men), or triglyceride levels > 150 mg/dL.
- Stable heterosexual partner relationship for the preceding 6 months.
Key exclusion criteria (12 listed)
- Pregnancy or less than 8 weeks postpartum.
- Diabetes mellitus (fasting glucose > 126 mg/dl.
- Uremia.
- Multiple sclerosis.
- Chronic alcoholism (intake of ≥ 500g/wk).
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 |
|---|---|---|
| fenofibratepill 145 mg, 145 mg/day, for 12 months | Drug | Fenofibrate |
| Rosuvastatinpills of 10 mg, 10 mg/day, 12 months | Drug | Rosuvastatin |
| fenofibrate + rosuvastatinfenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months | Drug | fenofibrate + rosuvastatin |
Primary outcome
International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women
Time frame: Baseline, 6 months, 12 months
1 secondary outcome
Blood lipids, inflammatory markers
Time frame: Baseline, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Background: PubMed 19453904Esposito K, Ciotola M, Maiorino MI, Giugliano F, Autorino R, De Sio M, Cozzolino D, Saccomanno F, Giugliano D. Hyperlipidemia and sexual function in premenopausal women. J Sex Med. 2009 Jun;6(6):1696-1703. doi: 10.1111/j.1743-6109.2009.01284.x. Epub 2009 Apr 23.
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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.
Dario Giugliano, MD,PhD principal investigator
Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fenofibrate, Rosuvastatin and fenofibrate + rosuvastatin in people with Sexual Dysfunction and Hyperlipidemia, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 18 Nov 2015. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 dysfunction (IIEF) in men and Female sexual function index (FSFI) in women (time frame: Baseline, 6 months, 12 months). 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 NCT00923676, 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 18 Nov 2015.