Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function (NCT03933618) | Clinical Trial Compass
CompletedPhase 2
Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
24 participantsStarted 2015-04-02
Plain-language summary
This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week intervals.
Who can participate
Age range
18 Years – 70 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when an affirmative answer (''yes'') to either questions "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or any three other questions.10
. Body mass index (BMI) \<40
. Sexual health inventory for men (SHIM) score \>7 and \<21. Patients are allowed to be taking phosphodiesterase 5 inhibitors (i.e. Viagra, Levitra, Cialis) at baseline, however we will ask them to do the SHIM survey as if they were not taking this medication.
. Men must attempt to have at least four sexual encounters over each of the eight-week periods
. Men willing not to take phosphodiesterase 5 inhibitors throughout the entire study
Exclusion criteria
. Current or previous history of prostate cancer
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used both anastrozole and clomiphene together to treat male hypogonadism — how does that combination approach compare to the testosterone replacement therapy you might already be considering for me, and why might one be preferred over the other in my situation?
2Since this was a Phase 2 trial that has now completed, has enough safety and effectiveness data been published for you to know whether this drug combination showed meaningful improvement in erectile function scores over the 24 weeks they measured?
3Clomiphene and anastrozole are not FDA-approved specifically for male hypogonadism — how does that 'off-label' status affect my options, and would my insurance be likely to cover either medication if we decided to explore this approach?
4The trial tracked erectile function using the IIEF questionnaire at 8, 16, and 24 weeks, which suggests this treatment requires several months to evaluate — given my current symptoms, is waiting that long to gauge whether something is working a realistic fit for my situation?
5Are there completed results from this trial I could review with you, and if the outcomes looked promising, is this combination something you would consider prescribing outside of a trial setting for someone with my specific hormone levels and symptoms?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IIEF (International Index of Erectile Function) Score - Screen
Timeframe: At baseline
2
IIEF (International Index of Erectile Function) Score - Week 8
Timeframe: Week 8
3
IIEF (International Index of Erectile Function) Score - Week 16
Timeframe: Week 16
4
IIEF (International Index of Erectile Function) Score - Week 24
. Previous or current androgen deprivation therapy for prostate cancer,
. Past surgical history of prostatectomy.
. History of testicular cancer.
. History of deep vein thrombosis (DVT) or blood dyscrasia
. History of breast cancer
. Men with past or current treatment for erectile dysfunction including MUSE (alprostodil), intracavernosal injections, penile prosthesis. Men not on treatment or men who are on phosphodiesterase inhibitors will be allowed to be in the study but must stop their use at the screening visit.