Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06856174 · ClinicalTrials.gov registry record · Phase 4
Menopausal HT for Women Living With HIV (HoT)
A Phase 4 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 105
- Enrollment target
NCT06856174: Recruiting Phase 4 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT06856174 is a Phase 4 study that is actively recruiting participants, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 105 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06856174, a Phase 4 study, is actively recruiting participants, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 105 participants
- Enrollment target
Study Summary
Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if: * There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV * Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV * Hormone therapy is safe and tolerable for women living with HIV
Primary Outcome
Change in self-reported mean VMS frequency per day from 5-week observation phase prior to randomization to the one-week period prior to week 12 visit following.
Interventions
- DRUG Micronized Progesterone
- DRUG Transdermal estradiol gel
- DRUG Placebo for estradiol gel
- DRUG Placebo for micronized progesterone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2026-04-09 |
| Est. Completion | 2027-09-20 |
| Phase | Phase 4 |
What NCT06856174 shows while recruiting
NCT06856174 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Micronized Progesterone is the first listed.
NCT06856174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06856174 about?
NCT06856174 is a clinical study titled "Menopausal HT for Women Living With HIV (HoT)". Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function,...
What is the current status of trial NCT06856174?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2026-04-09. Estimated completion is 2027-09-20.
What interventions are being tested in trial NCT06856174?
The interventions under investigation include: Micronized Progesterone (DRUG), Transdermal estradiol gel (DRUG), Placebo for estradiol gel (DRUG), Placebo for micronized progesterone (DRUG).
Who is sponsoring clinical trial NCT06856174?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06856174's enrollment target sits among peer trials
105 749th of 2000 higher than 1,247 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03372317 · 105 participants
Tau PET in Imaging and Cognition: Healthy Adults From 55-90
- NCT04253964 · 105 participants · Phase 2
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
- NCT04742452 · 105 participants · NA
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
- NCT04875429 · 105 participants · NA
Zenith® Fenestrated+ Clinical Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI