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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 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.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06856174
The ClinicalTrials.gov registry entry for NCT06856174 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Micronized Progesterone is the first listed.
NCT06856174 reports 0 study locations.
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.
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