Reproductive DisordersPhase 1NCT04975347
Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank
A Phase 1 study testing Naloxone in people with Reproductive Disorders, run by Stephanie B. Seminara, MD at 1 site in United States.
Trial summary
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Reproductive Disorders
- What is being tested?
- Naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2022to 8 Aug 2025
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years (women) OR 18-60 years (men)
- Genetic sequencing data available via Mass General Brigham Biobank
- All medical conditions stable and well controlled
- If applicable, willing to use birth control methods (as approved by a study medical professional) during protocol participation
- Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
- Negative urine drug screening panel
- Hemoglobin within sex-specific reference range
- For women, negative serum hCG pregnancy test
Who cannot join
- Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
- Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
- Current or recent use of a medication that affects the opioid pathway
- Active illicit drug use
- Excessive alcohol consumption (> 10 drinks/week)
- For women, pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in healthy subjects.
Read the detailed description
Arm 1 Assignment: Individuals will be assigned to group 1 or group 2 based on their genetic features.
Arm 2 Assignment: Each study subject will serve as their own control.
Delivery of Interventions:
- Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
- During the study, the subjects will complete the following
- Arm 1: Undergo frequent blood sampling for up to 12 hours
- Arm 2:
- Period 1: Blood sampling q10 min for up to 12 hours
- Period 2: Blood sampling q10 min for up to 12 hours with concurrent administration of naloxone bolus followed by a naloxone infusion
- Conditions
- Reproductive Disorders
- Being tested
- Naloxone
- Keywords
- naloxone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaloxoneDrug
One bolus and one infusion of naloxone
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | one period of frequent blood sampling with no medication administered |
| Arm 2 | Experimental | 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.) Receives: Drug: Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in Luteinizing Hormone (LH) pulse frequency
Change in LH pulse frequency before and during naloxone infusion
Measured: Two 12-hour periods
Difference in Average LH Pulse Frequency
difference in LH pulse frequency between variant-carriers and control participants
Measured: one 12-hour period
Secondary outcomes (1)
Average change in LH pulse amplitude
Change in LH pulse amplitude before and during naloxone infusion
Measured: Two 12-hour periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start3 Jun 2022
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive DisordersStudies 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie B. Seminara, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
- Investigators
- Stephanie Seminara, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975347
- Sponsor's protocol ID
- 313512
- Status last verified
- Dec 2025
- First submitted
- 15 Jul 2021
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank
- ClinicalTrials.gov ID
- NCT04975347
- Acronym / sponsor ID
- 313512
- Conditions
- Reproductive Disorders
- Keywords
- naloxone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Stephanie B. Seminara, MDUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 23 Jul 2021 (actual)
- 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.
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in healthy subjects.
Detailed description
Arm 1 Assignment: Individuals will be assigned to group 1 or group 2 based on their genetic features.
Arm 2 Assignment: Each study subject will serve as their own control.
Delivery of Interventions:
- Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
- During the study, the subjects will complete the following
- Arm 1: Undergo frequent blood sampling for up to 12 hours
- Arm 2:
- Period 1: Blood sampling q10 min for up to 12 hours
- Period 2: Blood sampling q10 min for up to 12 hours with concurrent administration of naloxone bolus followed by a naloxone infusion
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –one period of frequent blood sampling with no medication administered |
| Arm 2 | Experimental | Drug: Naloxoneone 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.) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-45 years (women) OR 18-60 years (men)
- Genetic sequencing data available via Mass General Brigham Biobank
- All medical conditions stable and well controlled
- If applicable, willing to use birth control methods (as approved by a study medical professional) during protocol participation
- Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
Key exclusion criteria (6 listed)
- Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
- Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
- Current or recent use of a medication that affects the opioid pathway
- Active illicit drug use
- Excessive alcohol consumption (> 10 drinks/week)
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 |
|---|---|---|
| NaloxoneOne bolus and one infusion of naloxone | Drug | Arm 2 |
Primary outcome
Average change in Luteinizing Hormone (LH) pulse frequency
Time frame: Two 12-hour periods
Change in LH pulse frequency before and during naloxone infusion
Difference in Average LH Pulse Frequency
Time frame: one 12-hour period
difference in LH pulse frequency between variant-carriers and control participants
1 secondary outcome
Average change in LH pulse amplitude
Time frame: Two 12-hour periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Stephanie Seminara, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naloxone in people with Reproductive Disorders, run by Stephanie B. Seminara, MD at 1 site 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 18 Feb 2026. 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average change in Luteinizing Hormone (LH) pulse frequency (time frame: Two 12-hour periods). The study lists 2 primary outcomes in all. 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 18 Feb 2026.