Study on Estriol Vaginal Ring for Treating Vaginal Atrophy in Postmenopausal Women

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for vaginal atrophy, a condition often experienced by postmenopausal women where the vaginal walls become thin, dry, and inflamed. The study will test a newly developed vaginal ring that releases estriol, a form of estrogen, in three different doses: 1 microgram per day, 10 micrograms per day, and 20 micrograms per day. There will also be a group using a placebo vaginal ring, which does not contain any active drug.

The purpose of the study is to evaluate how these different doses of estriol affect the vaginal tissue and pH levels over a period of 90 days. Participants will be randomly assigned to one of the treatment groups or the placebo group. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This helps ensure that the results are not biased.

Throughout the study, changes in the vaginal tissue and pH levels will be monitored to assess the effectiveness of the treatment. Additionally, a subgroup of participants will have their systemic exposure to estriol measured to understand how the body absorbs and processes the hormone. The trial aims to provide valuable information on the potential benefits of using estriol-releasing vaginal rings for treating vaginal atrophy in postmenopausal women.

1 joining the study

Upon joining the study, you will be assigned to one of the treatment groups. This assignment is random, and neither you nor the study team will know which group you are in. This is called a double-blind study.

2 treatment administration

You will receive a vaginal ring to use. This ring may contain one of three doses of the active substance estriol or it may be a placebo, which does not contain any active drug.

The doses of estriol in the rings are either 1 microgram per day, 10 micrograms per day, or 20 micrograms per day. The ring is designed for vaginal use and will be worn continuously.

3 duration of treatment

The treatment will last for 90 days. During this time, you will continue to use the vaginal ring as instructed.

4 monitoring and assessments

Throughout the study, there will be regular assessments to monitor changes in your condition. This includes evaluating the cytologic pattern of your vaginal lining and measuring your vaginal pH.

A subgroup of participants will also have their systemic exposure to estriol measured. This involves checking how much of the drug is present in your body over time.

5 end of treatment evaluation

At the end of the 90-day treatment period, there will be a final evaluation to assess the changes from the start of the study. This will include checking the vaginal maturation value, the percentage of vaginal superficial cells, and the percentage of vaginal parabasal cells.

The study will also determine the proportion of participants who have achieved a vaginal pH of 5 or lower.

Who Can Join the Study?

Age: You must be 45 years or older.
Postmenopausal state: You should have had your last natural menstrual period at least 1 year ago and have a blood test showing a hormone level called FSH of 40 IU/l or higher.
Vaginal Maturation Value: This is a test result that should be 50% or less at the start of the study.
Vaginal pH: Your vaginal pH level should be greater than 5.0 at the start of the study.
Symptoms of Vaginal Atrophy: You should have at least one symptom such as dryness, pain or burning sensation, itching, discharge, painful urination, urinary incontinence, or pain during intercourse. These symptoms should be rated at a score of 65 or higher on a scale used to measure them.
Smoking status: You should be a non-smoker or have quit smoking for at least 3 months.
Consent: You must provide written informed consent after being informed about the benefits and potential risks of the clinical trial, as well as details of the insurance covering participants in this trial.

Who Cannot Join the Study?

Patients who are not experiencing vaginal atrophy cannot participate. Vaginal atrophy is a condition where the walls of the vagina become thin and dry.
Only female patients can participate in this study.
Patients who are male cannot participate.
Patients who are considered part of a vulnerable population cannot participate. This means groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Dinox GmbH	Berlin	Germany
Dr. med. Friederike von Grone Fachärztin für Frauenheilkunde und Geburtshilfe	Hamburg	Germany
Interdisziplinäres Beckenbodenzentrum	Berlin	Germany

Other Sites

Site Name	City	Country
Frauenarzt-Praxis Erwin Göckeler-Leopold	Geseke	Germany
Sqyiiiqk Rdeyjot Cuemzbby iy Dmbr Rfofzgto awf Domdtzpmlbg Gpuh	Erfurt	Germany
Poioes Dba Nibv	Aachen	Germany
Pkjeeu Dar Pmrbmg	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	09.07.2025

Trial locations

Investigated drugs:

Estriol

Estriol Vaginal Ring is a newly developed treatment designed to help with vaginal atrophy, a condition that can occur in postmenopausal women. This condition often leads to symptoms like dryness, irritation, and discomfort in the vaginal area. The vaginal ring releases estriol, a form of estrogen, directly into the vaginal tissue. This helps to improve the health of the vaginal lining by making it thicker and more elastic, which can reduce symptoms and improve comfort. The trial is investigating how effective this treatment is by looking at changes in the vaginal cells and pH levels after 90 days of use. Additionally, the study is examining how much estriol enters the bloodstream in a subgroup of patients to ensure the treatment is safe and effective.

Vaginal atrophy – Vaginal atrophy is a condition characterized by the thinning, drying, and inflammation of the vaginal walls. It typically occurs when the body produces less estrogen, such as during menopause. The condition can lead to symptoms like vaginal dryness, itching, and discomfort during intercourse. As the condition progresses, the vaginal tissue becomes more fragile and less elastic. This can result in increased susceptibility to irritation and infection. Changes in the vaginal environment, such as increased pH levels, are also common as the condition develops.

Trial ID:

2024-514302-31-00

Protocol code:

1452est24ct

Trial Phase:

Therapeutic exploratory (Phase II)

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