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Gonadotropin-releasing Hormone Agonist
Opioid Antagonist Therapy for Low Testosterone
Phase 2
Waitlist Available
Led By Stephanie Seminara, MD
Research Sponsored by Stephanie B. Seminara, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For women: Not breastfeeding and not pregnant
Hemoglobin: Women - no less than 0.5 gm/dL below the lower limit of the reference range for normal women; Men - on adequate testosterone replacement therapy: normal male reference range, off testosterone replacement therapy: no lower than 0.5 gm/dL below the lower limit of the reference range for normal women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and during treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial uses hormone injections and naloxone to study their effects on people with low reproductive hormone levels due to an unknown cause. Kisspeptin and GnRH help increase hormone production, while naloxone blocks opioid effects. The goal is to understand how these treatments affect hormone levels in these patients.
Who is the study for?
This trial is for adults with low testosterone or estradiol due to hypogonadotropic hypogonadism (HH), who are not currently seeking fertility, and have stable medical conditions. Participants should not be on medications affecting reproductive functions, have no history of severe medication reactions, and must pass certain blood tests.
What is being tested?
The study is testing the impact of opioid antagonists like naloxone on the hormonal axis in people with idiopathic HH. It aims to understand how blocking opioids affects hormones that control reproductive functions using substances such as kisspeptin and GnRH.
What are the potential side effects?
Potential side effects may include reactions at injection sites, changes in mood or energy levels, gastrointestinal discomfort, headaches, and possible alterations in hormone levels which could affect various bodily functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or breastfeeding.
Select...
My hemoglobin levels are within the normal range for my gender.
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I have been diagnosed with hypogonadotropic hypogonadism and have low testosterone or estradiol levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before and during treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and during treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Average change in Luteinizing Hormone (LH) pulse frequency
Secondary study objectives
Pulse Rate
Side effects data
From 2008 Phase 3 trial • 19 Patients • NCT0071038518%
Mild Opioid Withdrawal
12%
urticaria
6%
chest discomfort
6%
vomiting
6%
dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combined for All Study Conditions
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: naloxoneExperimental Treatment1 Intervention
one period of frequent blood sampling with no medication administered; one period of frequent blood sampling with IV administration of naloxone (one bolus and an infusion over an up to 12-hour period.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone
2014
Completed Phase 3
~1290
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Hypogonadotropic Hypogonadism (HH) is commonly treated with therapies that aim to restore the function of the hypothalamic-pituitary-gonadal axis. One such treatment involves the use of opioid antagonists, which block opioid receptors and thereby influence the release of gonadotropin-releasing hormone (GnRH).
This blockade helps to increase the secretion of GnRH, which in turn stimulates the pituitary gland to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH). These hormones are crucial for the production of sex steroids and gametogenesis.
For HH patients, this mechanism is vital as it addresses the underlying hormonal deficiency, thereby improving symptoms and potentially restoring fertility.
Regulation of pituitary glycoprotein alpha-subunit secretion after administration of a luteinizing hormone-releasing hormone antagonist in normal men.Progestins increase endogenous opioid peptide activity in postmenopausal women.A mild ovarian stimulation strategy in women with poor ovarian reserve undergoing IVF: a multicenter randomized non-inferiority trial.
Regulation of pituitary glycoprotein alpha-subunit secretion after administration of a luteinizing hormone-releasing hormone antagonist in normal men.Progestins increase endogenous opioid peptide activity in postmenopausal women.A mild ovarian stimulation strategy in women with poor ovarian reserve undergoing IVF: a multicenter randomized non-inferiority trial.
Find a Location
Who is running the clinical trial?
Stephanie B. Seminara, MDLead Sponsor
9 Previous Clinical Trials
814 Total Patients Enrolled
Stephanie Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
771 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can stop my hormone therapy for a certain period if needed.Women must have a negative pregnancy test before joining the study, and another test may be done before taking the medication.I haven't taken drugs affecting my hormones except for treating my reproductive condition.Your blood tests for BUN, creatinine, AST, and ALT should not show high levels.You do not drink more than 10 alcoholic drinks per week.My other health conditions are stable and under control.Your MRI does not show any unusual findings in your pituitary or hypothalamus.Your thyroid stimulating hormone (TSH) and prolactin levels are within the normal range.Your blood pressure is within the normal range (systolic BP < 140 mm Hg, diastolic < 90 mm Hg).Your white blood cell, platelet counts, and TSH levels should be within a certain range, not too low or too high.I am not pregnant or breastfeeding.Your urine drug test must show that you are not using any drugs.My hemoglobin levels are within the normal range for my gender.You do not use opioid drugs.Your gonadotropin levels are lower than normal.I have been diagnosed with hypogonadotropic hypogonadism and have low testosterone or estradiol levels.
Research Study Groups:
This trial has the following groups:- Group 1: naloxone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.