Secondary HypogonadismPhase 2NCT02443090
Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men
A Phase 2 study testing fispemifene in people with Secondary Hypogonadism and Sexual Dysfunction, run by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) at 16 sites in United States.
Trial summary
To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Secondary Hypogonadism, Sexual Dysfunction, Erectile Dysfunction
- What is being tested?
- fispemifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 16 sitesUnited States
- Study dates
- May 2015to Apr 2016
- Phase
- Phase 2
- 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 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- A confirmed diagnosis of secondary hypogonadism
- Mild to moderate erectile dysfunction
- Ability to read, understand and complete diaries and questionnaires
- Ability to safely make sexual attempts during the course of the study
Who cannot join
- Primary hypogonadism
- Hypogonadism as a result of surgery, trauma, tumors or radiation of the hypothalamus or pituitary
- History or current diagnosis of breast cancer, prostate cancer and/or PSA level above ≥3.5 ng/mL
- Poorly controlled blood pressure, type 2 diabetes, thyroid disease; sleep apnea
- Elevated prolactin level
- Hemoglobin >17 g/dL or Hematocrit >50%
Show all 11Show fewer
- Use of transdermal or oral testosterone within 4 weeks, intramuscular testosterone therapy within 6 weeks, and testosterone pellets within 6 months prior to Screening and at any time throughout the study
- Use of another SERM or past participation in a trial with Fispemifene
- Use of medications known to alter the HPG axis
- Clinically significant findings on physical exam, screening labs, or other findings which would prevent safe participation in the study
- Participation in another clinical study in the last 30 days
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
The Urological Institute of Northeastern New York
Albany, New York, 12208
Meridien Research
Bradenton, Florida, 34208
Clinical Research of South Florida
Coral Gables, Florida, 33134
Physicians' Research Options LLC
Draper, Utah, 84020
AccuMed Research Associates
Garden City, New York, 11530
Bruce R. GIlbert, MD, PhD, PC
Great Neck, New York, 11022
Volunteer Research
Knoxville, Tennessee, 37920
Premier Urology Associates, LLC, dba AdvanceMed Research
Lawrence, New Jersey, 08648
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Well Pharma Medical Research
Miami, Florida, 33144
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Manhattan Medical Research Practice PLLC
New York, New York, 10016
Clinical Research Associates of Tidewater, Inc.
Norfolk, Virginia, 23507
San Diego Clinical Trials
San Diego, California, 92120
Genesis Research LLC
San Diego, California, 92123
Regional Urology, LLC
Shreveport, Louisiana, 71106
About this study
Official title: An 8-Week Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men
To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects.
Read the detailed description
This phase 2 study is a double-blind, placebo controlled, parallel arm study with a 4 week run-in and an 8-week treatment period. It will assess the safety and tolerability of fispemifene, and the effects of treatment on the sexual side effects seen in this patient population using PRO endpoints.
- Being tested
- fispemifene, Placebo
- Keywords
- secondary hypogonadism, sexual dysfunction, erectile dysfunction
- Medical subject headings
- Hypogonadism, Sexual Dysfunction, Physiological, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fispemifeneDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Fispemifene 450 mg | Experimental | Fispemifene capsules will be taken orally each morning immediately after eating a meal Receives: Drug: fispemifene |
| Placebo | Placebo comparator | Placebo capsules will be taken orally each morning immediately after eating a meal Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score
Change in the IIEF-EF (International Index of Erectile Function - erectile function domain) score from Randomization to Week 8
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMay 2015
- 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.
- Other trials for Secondary HypogonadismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Troupin, MD, MBA, Study director, NexMed (U.S.A.), Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443090
- Sponsor's protocol ID
- NM-F15-202
- Status last verified
- Nov 2015
- First submitted
- 11 May 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men
- ClinicalTrials.gov ID
- NCT02443090
- Acronym / sponsor ID
- NM-F15-202
- Keywords
- secondary hypogonadism, sexual dysfunction, erectile dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 13 May 2015 (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.
To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects.
Detailed description
This phase 2 study is a double-blind, placebo controlled, parallel arm study with a 4 week run-in and an 8-week treatment period. It will assess the safety and tolerability of fispemifene, and the effects of treatment on the sexual side effects seen in this patient population using PRO endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fispemifene 450 mg | Experimental | Drug: fispemifeneFispemifene capsules will be taken orally each morning immediately after eating a meal |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules will be taken orally each morning immediately after eating a meal |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A confirmed diagnosis of secondary hypogonadism
- Mild to moderate erectile dysfunction
- Ability to read, understand and complete diaries and questionnaires
- Ability to safely make sexual attempts during the course of the study
Key exclusion criteria (11 listed)
- Primary hypogonadism
- Hypogonadism as a result of surgery, trauma, tumors or radiation of the hypothalamus or pituitary
- History or current diagnosis of breast cancer, prostate cancer and/or PSA level above ≥3.5 ng/mL
- Poorly controlled blood pressure, type 2 diabetes, thyroid disease; sleep apnea
- Elevated prolactin level
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 |
|---|---|---|
| fispemifene | Drug | Fispemifene 450 mg |
| Placebo | Other | Placebo |
Primary outcome
Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score
Time frame: 8 weeks
Change in the IIEF-EF (International Index of Erectile Function - erectile function domain) score from Randomization to Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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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.
Barbara Troupin, MD, MBA study director
NexMed (U.S.A.), Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fispemifene in people with Secondary Hypogonadism and Sexual Dysfunction, run by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) at 16 sites in United States.
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 11 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 13 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 16 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2015.