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Opioid Antagonist

Naloxone for Reproductive Disorders

Phase 1
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 men: Testicular volume >15 ml by Prader orchidometer
No prescription medications for at least 2 months except for seasonal allergy medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two 13-hour periods
Awards & highlights

Study Summary

This trial will test if taking an opioid antagonist improves the function of the hypothalamic-pituitary-gonadal axis in healthy people.

Who is the study for?
Healthy individuals with normal puberty development, no chronic diseases or emergency medication reactions, not on prescriptions except for allergy meds, and not seeking fertility. Must have a BMI between 18.5-30, normal blood pressure and lab results within specific ranges. Men should have normal reproductive function; women need regular menstrual cycles and can't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study is testing the impact of opioid antagonists like kisspeptin 112-121, GnRH, and Naloxone on the hormonal system that controls reproduction in healthy subjects to understand how these drugs affect hormone levels.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical drug reactions such as nausea, headaches, dizziness or allergic responses given that opioid antagonists will be used which can influence various bodily functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My testicular volume is more than 15 ml.
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I haven't taken any prescription meds in the last 2 months, except for allergy meds.
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I am not pregnant or breastfeeding.
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I do not have any long-term illnesses.
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My puberty started and progressed normally.
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My blood pressure is below 140/90 mm Hg.
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I have no issues with having my blood drawn.
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My drug test results were negative.
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I do not have excessive hair growth or severe acne.
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I am a man with normal sexual function and no history of reproductive issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two 13-hour periods
This trial's timeline: 3 weeks for screening, Varies for treatment, and two 13-hour periods for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average change in Luteinizing Hormone (LH) pulse frequency
Secondary outcome measures
Average change in LH pulse amplitude

Side effects data

From 2009 Phase 2 trial • 36 Patients • NCT00586898
22%
Hyperglycemia
19%
Hot Flashes
17%
Dyspnea
14%
Hyperkalemia
8%
SGPT (ALT)
6%
Hypoglycemia
3%
Pneumonitis
3%
Cardiovascular, other
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Participants

Trial Design

1Treatment groups
Experimental Treatment
Group I: kisspeptin, GnRH, naloxoneExperimental Treatment3 Interventions
Arm Description: IV administration of kisspeptin 112-121; six boluses in two up to 13-hour periods. IV administration of GnRH; two boluses in two up to 13-hour periods. IV administration of naloxone; one bolus and an infusion over an up to 13-hour period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
kisspeptin 112-121
2013
Completed Phase 1
~120
GnRH
2017
Completed Phase 2
~320
Naloxone
2014
Completed Phase 3
~1240

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor
9 Previous Clinical Trials
1,317 Total Patients Enrolled
Stephanie Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
745 Total Patients Enrolled

Media Library

Naloxone (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04975347 — Phase 1
Reproductive Disorders Research Study Groups: kisspeptin, GnRH, naloxone
Reproductive Disorders Clinical Trial 2023: Naloxone Highlights & Side Effects. Trial Name: NCT04975347 — Phase 1
Naloxone (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975347 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what ways is the hormone GnRH utilized therapeutically?

"GnRH is frequently employed to treat opioid addiction, but it has been known to ameliorate pain and itching symptoms as well as septic shock."

Answered by AI

Are there any regulatory approvals for GnRH usage?

"Our team's assessment of GnRH has placed it at a score of 1, indicating that clinical data on its safety and efficacy is quite limited."

Answered by AI

Is this experimental research open to elderly participants?

"The cut off for patient enrolment in this clinical trial is between 21 and 40 years old."

Answered by AI

Are there any precedents of GnRH being used in a medical experiment?

"Presently, 80 studies on GnRH are underway. Of those in progress, 19 have reached Phase 3 status. Based out of White River Junction, Vermont, the scope of these clinical trials is expansive with 1436 locations offering this treatment regimen."

Answered by AI

What is the maximum capacity of participants accepted for this clinical trial?

"Currently, this clinical trial is not actively recruiting patients. It was initially uploaded on the 3rd of June 2022 and its last update occurred on the 29th of June 2022. If you are in search for other medical studies, there are 1 trials seeking participants with reproductive disorders and 80 GnRH related investigations that are enrolling patients as we speak."

Answered by AI

Is this research endeavor actively seeking new participants?

"This medical study has closed registration and is no longer seeking patients. It was initially posted on June 3rd, 2022 but as of June 29th it had ceased to accept new participants. However, there are 1 studies looking for individuals with reproductive disorders and 80 trials involving GnRH that are open to enrollment right now."

Answered by AI

What type of individuals is this clinical trial specifically targeting?

"This research trial requires 23 individuals aged 21-40 with reproductive disorders to qualify. Additionally, candidates should have experienced a normal puberty and not be taking any medications (except seasonal allergies), engaging in illicit drug use or excessive alcohol consumption (>10 drinks/week). Furthermore, participants must not have had prior medical reactions requiring emergency care and possess an adequate BMI (18.5 - 30 kg/m2) as well as normal blood pressure readings (<140 mmHg systolic & <90 mmHg diastolic)."

Answered by AI
~9 spots leftby May 2025