Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial

  • STATUS
    Recruiting
Updated on 3 March 2021

Summary

The goal of this research study is to understand whether aging affects vaginal health differently in menopausal women living with and without HIV and whether vaginal estradiol improves symptoms of vaginal atrophy in menopausal women living with HIV. 

Description

The first goal of this two-part research study is to understand whether aging affects vaginal health differently in menopausal women living with and without HIV. We want to determine if having HIV is associated with accelerated vaginal aging including earlier changes in the amount and types of vaginal bacteria and inflammation.

Some menopausal women develop a condition known as vaginal atrophy, which causes uncomfortable symptoms such as irritation, pain with sex, dryness and itching. The second part of this study it to determine whether treatment with vaginal estradiol improves these vaginal symptoms and measures of vaginal health in menopausal women living with HIV.

We will study whether menopausal women with HIV have improvement in vaginal atrophy symptoms and aging associated changes in the vagina (bacteria, inflammation) after using a vaginal estradiol tablet (Vagifem® 10 μg) for 12 weeks.

Participants in this part of the study will be randomly assigned to receive treatment with Vagifem or no treatment. An estradiol tablet placed inside the vagina may prevent or delay the aging process, lead to fewer changes in the types of bacteria present in the vagina, improve vaginal atrophy symptoms and ultimately keep the vagina healthier for a longer period of time.

This is especially important for women with HIV as they are living longer, healthier, sexually active lives because the virus is controlled with medication. Vagifem is safe, effective, and FDA approved for the treatment of symptomatic vaginal atrophy.

Procedures: Participation in both parts of the study involves answering questions about your medical and sexual history, surveys, blood draws, pelvic exam, vaginal biopsies, and vaginal swabs. Participation in Part 2 also involves using an estradiol vaginal tablet for 12 weeks.

Compensation: Participants will be compensated commensurate with the parts in which they enroll. Participants who only complete Part 1 will be reimbursed $125. Participants who only complete Part 2 will be reimbursed $250. Participants who complete all study visits (Part 1 and Part 2) will be reimbursed $300.

Details
Condition Aging
Clinical Study IdentifierTX253155
Last Modified on3 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 45 yrs and 70 yrs?
Are you female?
Do you have Aging?
Do you have any of these conditions: Do you have Aging??
Do you have any of these conditions: Do you have Aging??
Female
Between the ages of 45 and 70
Menopausal, defined as having no periods in the last 12 months
Living with or without HIV
With or without vaginal atrophy symptoms

Exclusion Criteria

You do not qualify to take part in either part of the study if you have any of the following
Unexplained or unevaluated abnormal genital bleeding
Current or suspected pregnancy
If < age 55, had a hysterectomy and has at least one ovary
Pelvic or vaginal surgery in the prior 60 days
Used systemic reproductive hormones in the last 2 months
Used antibiotics in the last 30 days
Used immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post-transplant immunosuppressive medications
Used any vaginal or vulvar preparations in the last month
Current active vaginal infection diagnosed at study entry
Any serious disease or condition that may interfere with study compliance
You do not qualify for Part 2 of the study (Clinical Trial) if you have any of the following additional conditions
Current or previous history of breast cancer or estrogen-dependent cancer (e.g. ovarian, endometrial)
Current or previous history of deep vein thrombosis or pulmonary embolism
Current or previous history of myocardial infarction or stroke
Known clotting disorder including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations
Known severe liver disease including cirrhosis or active Hepatitis B
Known allergic reaction to Vagifem (estradiol vaginal tablet)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note