Premature Ovarian InsufficiencyPhase 3NCT06851754
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
A Phase 3 study testing Progesterone and Estrogen Patch in people with Premature Ovarian Insufficiency, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Background: Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms. Read more about this study
- Who is it for?
- Ages 11 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- Progesterone and Estrogen Patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2025to 31 Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 11 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Individuals aged 11-19 years, inclusive, at the time of enrollment.
- Diagnosis of premature ovarian insufficiency.
- Documentation of one elevated serum FSH measurement greater than the testing laboratory's upper reference range (for age/Tanner stage).
- Identify as female (i.e., sex assigned at birth)
- Negative pregnancy test.
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- Individuals aged 11-19 years.
- Identify as female (i.e., sex assigned at birth)
- Negative pregnancy test.
- Absence of known chronic disease
Who cannot join
- Male participants are excluded from both study groups (POI and Healthy Volunteers) as POI affects only the female reproductive system, while pregnant participants are not eligible to have DXA or HRpQCT imaging for safety reasons.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- POI in the setting of Turner syndrome.
- Patients who screened positive for celiac disease.
- Receipt of any medications including HRT determined by the investigator to affect bone metabolism 3 months prior to enrollment.
- Any medical condition determined by the investigator to affect bone health will be excluded.
Show all 9Show fewer
- Presence of a medical, psychiatric, or social condition which, in the opinion of the investigator, would place undue burden on the subject, NIH resources, or increase risk of participation.
- Report of sexual activity but refusal to use a copper intrauterine device or double barrier forms of contraception during the study.
- For healthy volunteers, all exclusion criteria will apply as for POI participants except for number 1.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Background:
Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms. Hormone replacement therapy (HRT) is a treatment that gives women extra hormones, such as estrogen and progesterone. HRT works well in adult women. Researchers want to find the most effective doses and regimens for adolescents.
Read more
Objective:
To monitor the effects of HRT on adolescents with POI.
Eligibility:
Female adolescents aged 11 to 19 years diagnosed with POI. Healthy volunteers are also needed.
Design:
All participants will have clinic visits every 6 months for 2 years. Each visit may last 2 days. Each visit may include:
Blood and urine tests.
A test of their heart function.
A test to measure the stiffness of their blood vessels. Participants will lie flat with a blood pressure cuff on a leg and a meter on the neck while the cuff inflates.
A test of their grip strength. Participants will squeeze a handheld device as hard as they can.
Two scans to measure bone density. For one, participants will lie on a table while a scanner passes along their body. For the other, participants will sit in a chair and insert their forearm, then their lower leg, into a scanner.
A test to measure skin pigmentation. Participants' skin will be touched lightly with a device.
An optional visual exam of the vagina. Some vaginal fluid may also be collected with a cotton swab/cytobrush.
Participants with POI will receive HRT. They will be given estrogen patches and progesterone pills.
Read the detailed description
Study Description:
This is a study of adolescents with premature ovarian insufficiency (POI) and their response to hormone replacement therapy (HRT).
Objectives:
Primary:
To identify the phenotype and associated genotype of adolescents with POI at the time of diagnosis, including assessment of overall bone health of participants pre- and post-HRT treatment with respect to bone mineral density (BMD) and other skeletal endpoints.
Bone Health:
-Follow patients with POI for bone health assessments:
- Measure BMD at different skeletal sites, including the central skeleton (lumbar spine, total body less head, and hip - femoral neck and total hip)
- Perform vertebral fracture assessment (VFA)
- Determine body composition of lean body and fat mass (total body) and correlate with BMD.
- Assess skin pigmentation and muscle grip strength and correlate with BMD
Secondary:
Bone Health
-Follow patients with POI for bone health assessments:
- Measure BMD at peripheral skeleton (radius and tibia)
- Evaluate bone microarchitecture and strength of the radius and tibia.
Metabolic Phenotype:
- Follow patients with POI for metabolic assessment:
- Insulin resistance
- Cardiovascular risk
- Lipid profiles
- Bone turnover
Muscle Phenotype:
-Follow patients with POI for muscle function assessment:
- Determine hand grip muscle strength
- Evaluate lean body mass (by DXA) to determine muscle mass
Cardiovascular Health
-Follow patients with POI for a cardiovascular evaluation:
- Electrophysiologic parameters (from 12-lead EKG)
- Arterial stiffness (by Pulse Wave Velocity, PWV)
- Coagulation studies to determine the impact of HRT on clotting function
Genetic profiling:
-If obtained, assess the baseline genotype of patients with POI to correlate with BMD and other health outcomes
--If subjects are co-enrolled on NIAID protocol 17I0122, utilize that genetic sequencing data to associate with genotype and response of multiple health outcomes to HRT.
Quality of Life:
-Follow patients with POI for evaluation of an individual s perception of their life quality and health:
- Evaluate the individual s perceived occupational performance in self-care, productivity, and leisure
- Evaluate the individual s occupations or hobbies that align with their interests
Psychological health:
-Follow patients with POI for evaluation of an individual s mood and well-being:
- Measure symptoms and severity of depression
- Measure the state and trait components of anxiety
Menopause profile:
-Follow patients with POI for determining signs and symptoms of menopause:
- Evaluate reproductive hormonal changes
- Assess menopausal symptoms and their severity
- Evaluate vaginal health
Hormone Replacement Therapy:
-Follow patients with POI longitudinally to determine the most effective HRT management:
- Evaluate dosage, delivery, combination of HRT
- Evaluate effects of HRT on bone, cardiovascular, metabolic, gynecologic, and psychological health
Endpoints:
Primary:
Longitudinal evaluation of BMD of the central skeleton (lumbar spine).
As secondary measures of bone health, dual-energy x-ray absorptiometry (DXA) measures of skeletal sites other than the spine (DXA - hip/total body) will be evaluated longitudinally in POI participants and their BMD compared to healthy control participants. Using DXA, vertebral fractures assessment (VFA) will be performed in POI participants and compared to healthy control participants. In addition, BMD will be evaluated with respect to skin pigmentation and muscle grip strength.
Secondary:
- High-resolution peripheral quantitative computed tomography (HRpQCT) bone density and strength measures by HRpQCT of the peripheral skeleton (radius and tibia) will be evaluated longitudinally in participants with POI and their BMD compared to healthy control participants.
- Compare metabolic and cardiovascular parameters in participants with POI to healthy controls.
- Compare muscle phenotype in participants with POI to healthy controls by measuring muscle strength using hand grip dynamometry and measuring lean body mass (as measure of total body muscle mass) by DXA.
- Compare repolarization changes (by 12-lead EKG), arterial stiffness (by PWV) and coagulation parameters in participants with POI to healthy controls.
- Compare genetic background of participants with POI to healthy controls using whole genome sequencing.
- Evaluate quality of life with Canadian Occupational Performance Measure (COPM) and Interest Checklist questionnaires.
- Evaluate psychological health of participants with POI compared to healthy controls using the Beck Depression Inventory and Spielberger State/Trait Anxiety Inventory.
- Evaluate menopausal profile in participants with POI compared to healthy controls by detecting changes in ovarian hormonal levels and correlating with responses on the Menopause Rating Scale, and vaginal cytology and degree of atrophy after HRT compared to baseline (and participants vs. controls).
- Compare health effects from a typical clinical HRT regiment over the course of 2 years of administration.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- Progesterone, Estrogen Patch
- Keywords
- Premature Ovarian Insufficiency, Hormone Replacement Therapy, Adolescents, Bone Health
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Oral micronized progesterone will be added (100 mg/day for 12 days/month) in the event of spontaneous vaginal bleeding and/or at 12 months over the 2-year protocol.
Estrogen PatchDrug
participants with POI (n=85) will receive transdermal 17 beta-estradiol (beginning at a dose of 25 microgram/patch applied weekly), with the dose increased at 3 months to 50 microgram, and thereafter every 6 months to 75 and 100 microgram/patch for pubertal induction or estrogen replacement (with 100 microgram/patch representing a full adolescent or young adult estradiol dose). The continued escalation of the estradiol dose and patch strength will be guided by the clinical presentation and physical examination (by the PI or designated AI).
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | No intervention | Healthy Control Participants |
| POI Patients | Experimental | POI patients will be receiving transdermal 17 beta-estradiol and oral micronized progesterone. Receives: Drug: Progesterone; Drug: Estrogen Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal evaluation of BMD of the central skeleton (lumbar spine).
measures of bone health, dual-energy x-ray absorptiometry (DXA) measures of skeletal sites other than the spine (DXA - hip/total body) will be evaluated longitudinally in POI participants and their BMD compared to healthy control participants. Using DXA, vertebral fractures assessment (VFA) will be performed in POI participants and compared to healthy control participants. In addition, BMD will be evaluated with respect to skin pigmentation and muscle grip strength.
Measured: 2 years
Secondary outcomes (9)
Evaluate bone density and strength of the radius and tibia in participants with POI and compare with healthy controls.
Bone Health - Evaluate bone density and strength of the radius and tibia in participants with POI and compare with healthy controls.
Measured: 2 years
Compare metabolic and cardiovascular parameters between participants with POI and healthy controls.
Metabolic Phenotype - Compare metabolic and cardiovascular parameters between participants with POI and healthy controls.
Measured: 2 years
Assess muscle strength and lean body mass in participants with POI compared to healthy controls.
Muscle Phenotype - Assess muscle strength and lean body mass in participants with POI compared to healthy controls.
Measured: 2 years
Analyze heart repolarization, arterial stiffness, and coagulation parameters in participants with POI versus healthy controls.
Cardiovascular Health - Analyze heart repolarization, arterial stiffness, and coagulation parameters in participants with POI versus healthy controls.
Measured: 2 years
Compare the genetic background of participants with POI to healthy controls using whole genome sequencing.
Genetic profiling - Compare the genetic background of participants with POI to healthy controls using whole genome sequencing.
Measured: 2 years
Assess quality of life using COPM and Interest Checklist questionnaires.
Quality of Life - Assess quality of life using COPM and Interest Checklist questionnaires.
Measured: 2 years
Evaluate psychological health using the Beck Depression Inventory and Spielberger State/Trait Anxiety Inventory.
Psychological Health - Evaluate psychological health using the Beck Depression Inventory and Spielberger State/Trait Anxiety Inventory.
Measured: 2 years
Compare menopausal profile, including ovarian hormone levels and responses to the Menopause Rating Scale, between participants with POI and healthy controls.
Menopausal profile - Compare menopausal profile, including ovarian hormone levels and responses to the Menopause Rating Scale, between participants with POI and healthy controls.
Measured: 2 years
Assess health effects of a typical clinical HRT regimen over two years.
Hormone Replacement Therapy - Assess health effects of a typical clinical HRT regimen over two years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start17 Jul 2025
- Primary completion1 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Catherine M Gordon, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851754
- Sponsor's protocol ID
- 10002141
- Other IDs
- 002141-CH
- Status last verified
- 27 Oct 2026
- First submitted
- 25 Feb 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be deposited into a data repository in line with NIH regulations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT06851754
- Acronym / sponsor ID
- 10002141
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- Premature Ovarian Insufficiency, Hormone Replacement Therapy, Adolescents, Bone Health
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 28 Feb 2025 (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.
Background:
Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms. Hormone replacement therapy (HRT) is a treatment that gives women extra hormones, such as estrogen and progesterone. HRT works well in adult women. Researchers want to find the most effective doses and regimens for adolescents.
Objective:
To monitor the effects of HRT on adolescents with POI.
Eligibility:
Female adolescents aged 11 to 19 years diagnosed with POI. Healthy volunteers are also needed.
Design:
All participants will have clinic visits every 6 months for 2 years. Each visit may last 2 days. Each visit may include:
Blood and urine tests.
A test of their heart function.
A test to measure the stiffness of their blood vessels. Participants will lie flat with a blood pressure cuff on a leg and a meter on the neck while the cuff inflates.
A test of their grip strength. Participants will squeeze a handheld device as hard as they can.
Two scans to measure bone density. For one, participants will lie on a table while a scanner passes along their body. For the other, participants will sit in a chair and insert their forearm, then their lower leg, into a scanner.
A test to measure skin pigmentation. Participants' skin will be touched lightly with a device.
An optional visual exam of the vagina. Some vaginal fluid may also be collected with a cotton swab/cytobrush.
Participants with POI will receive HRT. They will be given estrogen patches and progesterone pills.
Detailed description
Study Description:
This is a study of adolescents with premature ovarian insufficiency (POI) and their response to hormone replacement therapy (HRT).
Objectives:
Primary:
To identify the phenotype and associated genotype of adolescents with POI at the time of diagnosis, including assessment of overall bone health of participants pre- and post-HRT treatment with respect to bone mineral density (BMD) and other skeletal endpoints.
Bone Health:
-Follow patients with POI for bone health assessments:
- Measure BMD at different skeletal sites, including the central skeleton (lumbar spine, total body less head, and hip - femoral neck and total hip)
- Perform vertebral fracture assessment (VFA)
- Determine body composition of lean body and fat mass (total body) and correlate with BMD.
- Assess skin pigmentation and muscle grip strength and correlate with BMD
Secondary:
Bone Health
-Follow patients with POI for bone health assessments:
- Measure BMD at peripheral skeleton (radius and tibia)
- Evaluate bone microarchitecture and strength of the radius and tibia.
Metabolic Phenotype:
- Follow patients with POI for metabolic assessment:
- Insulin resistance
- Cardiovascular risk
- Lipid profiles
- Bone turnover
Muscle Phenotype:
-Follow patients with POI for muscle function assessment:
- Determine hand grip muscle strength
- Evaluate lean body mass (by DXA) to determine muscle mass
Cardiovascular Health
-Follow patients with POI for a cardiovascular evaluation:
- Electrophysiologic parameters (from 12-lead EKG)
- Arterial stiffness (by Pulse Wave Velocity, PWV)
- Coagulation studies to determine the impact of HRT on clotting function
Genetic profiling:
-If obtained, assess the baseline genotype of patients with POI to correlate with BMD and other health outcomes
--If subjects are co-enrolled on NIAID protocol 17I0122, utilize that genetic sequencing data to associate with genotype and response of multiple health outcomes to HRT.
Quality of Life:
-Follow patients with POI for evaluation of an individual s perception of their life quality and health:
- Evaluate the individual s perceived occupational performance in self-care, productivity, and leisure
- Evaluate the individual s occupations or hobbies that align with their interests
Psychological health:
-Follow patients with POI for evaluation of an individual s mood and well-being:
- Measure symptoms and severity of depression
- Measure the state and trait components of anxiety
Menopause profile:
-Follow patients with POI for determining signs and symptoms of menopause:
- Evaluate reproductive hormonal changes
- Assess menopausal symptoms and their severity
- Evaluate vaginal health
Hormone Replacement Therapy:
-Follow patients with POI longitudinally to determine the most effective HRT management:
- Evaluate dosage, delivery, combination of HRT
- Evaluate effects of HRT on bone, cardiovascular, metabolic, gynecologic, and psychological health
Endpoints:
Primary:
Longitudinal evaluation of BMD of the central skeleton (lumbar spine).
As secondary measures of bone health, dual-energy x-ray absorptiometry (DXA) measures of skeletal sites other than the spine (DXA - hip/total body) will be evaluated longitudinally in POI participants and their BMD compared to healthy control participants. Using DXA, vertebral fractures assessment (VFA) will be performed in POI participants and compared to healthy control participants. In addition, BMD will be evaluated with respect to skin pigmentation and muscle grip strength.
Secondary:
- High-resolution peripheral quantitative computed tomography (HRpQCT) bone density and strength measures by HRpQCT of the peripheral skeleton (radius and tibia) will be evaluated longitudinally in participants with POI and their BMD compared to healthy control participants.
- Compare metabolic and cardiovascular parameters in participants with POI to healthy controls.
- Compare muscle phenotype in participants with POI to healthy controls by measuring muscle strength using hand grip dynamometry and measuring lean body mass (as measure of total body muscle mass) by DXA.
- Compare repolarization changes (by 12-lead EKG), arterial stiffness (by PWV) and coagulation parameters in participants with POI to healthy controls.
- Compare genetic background of participants with POI to healthy controls using whole genome sequencing.
- Evaluate quality of life with Canadian Occupational Performance Measure (COPM) and Interest Checklist questionnaires.
- Evaluate psychological health of participants with POI compared to healthy controls using the Beck Depression Inventory and Spielberger State/Trait Anxiety Inventory.
- Evaluate menopausal profile in participants with POI compared to healthy controls by detecting changes in ovarian hormonal levels and correlating with responses on the Menopause Rating Scale, and vaginal cytology and degree of atrophy after HRT compared to baseline (and participants vs. controls).
- Compare health effects from a typical clinical HRT regiment over the course of 2 years of administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | No intervention | –Healthy Control Participants |
| POI Patients | Experimental | Drug: Progesterone, Drug: Estrogen PatchPOI patients will be receiving transdermal 17 beta-estradiol and oral micronized progesterone. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Individuals aged 11-19 years, inclusive, at the time of enrollment.
- Diagnosis of premature ovarian insufficiency.
- Documentation of one elevated serum FSH measurement greater than the testing laboratory's upper reference range (for age/Tanner stage).
- Identify as female (i.e., sex assigned at birth)
Key exclusion criteria (9 listed)
- Male participants are excluded from both study groups (POI and Healthy Volunteers) as POI affects only the female reproductive system, while pregnant participants are not eligible to have DXA or HRpQCT imaging for safety reasons.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- POI in the setting of Turner syndrome.
- Patients who screened positive for celiac disease.
- Receipt of any medications including HRT determined by the investigator to affect bone metabolism 3 months prior to enrollment.
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 |
|---|---|---|
| ProgesteroneOral micronized progesterone will be added (100 mg/day for 12 days/month) in the event of spontaneous vaginal bleeding and/or at 12 months over the 2-year protocol. | Drug | POI Patients |
| Estrogen Patchparticipants with POI (n=85) will receive transdermal 17 beta-estradiol (beginning at a dose of 25 microgram/patch applied weekly), with the dose increased at 3 months to 50 microgram, and thereafter every 6 months to 75 and 100 microgram/patch for pubertal induction or estrogen replacement (with 100 microgram/patch representing a full adolescent or young adult estradiol dose). The continued escalation of the estradiol dose and patch strength will be guided by the clinical presentation and physical examination (by the PI or designated AI). | Drug | POI Patients |
Primary outcome
Longitudinal evaluation of BMD of the central skeleton (lumbar spine).
Time frame: 2 years
measures of bone health, dual-energy x-ray absorptiometry (DXA) measures of skeletal sites other than the spine (DXA - hip/total body) will be evaluated longitudinally in POI participants and their BMD compared to healthy control participants. Using DXA, vertebral fractures assessment (VFA) will be performed in POI participants and compared to healthy control participants. In addition, BMD will be evaluated with respect to skin pigmentation and muscle grip strength.
9 secondary outcomes
Evaluate bone density and strength of the radius and tibia in participants with POI and compare with healthy controls.
Time frame: 2 years
Compare metabolic and cardiovascular parameters between participants with POI and healthy controls.
Time frame: 2 years
Assess muscle strength and lean body mass in participants with POI compared to healthy controls.
Time frame: 2 years
Analyze heart repolarization, arterial stiffness, and coagulation parameters in participants with POI versus healthy controls.
Time frame: 2 years
Compare the genetic background of participants with POI to healthy controls using whole genome sequencing.
Time frame: 2 years
Assess quality of life using COPM and Interest Checklist questionnaires.
Time frame: 2 years
Evaluate psychological health using the Beck Depression Inventory and Spielberger State/Trait Anxiety Inventory.
Time frame: 2 years
Compare menopausal profile, including ovarian hormone levels and responses to the Menopause Rating Scale, between participants with POI and healthy controls.
Time frame: 2 years
Assess health effects of a typical clinical HRT regimen over two years.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be deposited into a data repository in line with NIH regulations.
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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.
Catherine M Gordon, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progesterone and Estrogen Patch in people with Premature Ovarian Insufficiency, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine M Gordon, M.D. ((301) 827-5449, catherine.gordon@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal evaluation of BMD of the central skeleton (lumbar spine). (time frame: 2 years). 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 29 Oct 2026.