Polynucleotides Efficacy in the Genitourinary Syndrome of Menopause

Sponsor

Hospital Regional 1o de Octubre (Other)

Overall Status

Recruiting

CT.gov ID

NCT05464654

Collaborator

Institut d'Investigacions Biomèdiques August Pi i Sunyer (Other), Hospital General Regional No. 1 IMSS (Other), Universidad Nacional Autonoma de Mexico (Other), National Polytechnic Institute, Mexico (Other)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine the efficiency of local polynucleotides-based therapy in the treatment of the genitourinary syndrome of menopause, in postmenopausal Mexican women, and to compare it with gold standard therapy with local conjugated estrogens.

Condition or Disease	Intervention/Treatment	Phase
Genitourinary Syndrome of Menopause Postmenopausal Disorder Menopause Vagina Atrophy	Drug: 3 g Polynucleotide vaginal suppositories Drug: Conjugated estrogens cream 1g Tube	N/A

Detailed Description

First-time participants from the climacteric and bone metabolism clinic were enrolled, referred by the family medicine service or by another service of the Regional Hospital October 1st- ISSSTE. Initially, 30 participants with genitourinary syndrome of menopause (GSM) diagnosis that presented an MRS > 5 in the urogenital domain, with alterations in the vaginal maturity index (VMI) and in the vaginal pH, were enrolled to perform the pilot study. Participants were assigned to the experimental group and the control group in each consultation, in a non-randomised manner. Participants were assigned as they arrived at the consultation, assigning one participant to the experimental group and one to the control group on each occasion. 15 participants were assigned to the control group (n=15), which received estrogen-based local hormone therapy with local conjugated estrogens cream, applied topically to the vagina mucosa on Monday, Wednesday, and Friday of each week, for three months. The other 15 participants were assigned to the experimental group (n=15), which received PN-based local therapy intravaginally applied (IV) every night, for six days. Then, experimental group participants were maintained without further treatment up to the control evaluation.

The pilot study was performed from June 23th 2021 to December 23 th 2021. After completing the pilot study, 120 participants have been recruited to perform the randomized clinical trial. For that trial, 60 participants will be assigned to the control group that will receive estrogen-based local hormone therapy with local conjugated estrogens cream, applied topically to the vagina mucosa on Monday, Wednesday, and Friday of each week, for three months. The other 60 participants will be assigend to the experimental group that will receive polynucleotides-based therapy intravaginally applied (IV) every night, for six days. The participants will be assigned in a randomized manner to each group.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Initially, a parallel pilot study was done, where 30 participants from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE) were enrolled. After completing the pilot study, a randomized clinical trial was started, where 120 participants will be enrolled.Initially, a parallel pilot study was done, where 30 participants from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE) were enrolled. After completing the pilot study, a randomized clinical trial was started, where 120 participants will be enrolled.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Local Polynucleotides-based Therapy Improves the Genitourinary Syndrome of Menopause and Promotes Vaginal Bio-revitalization

Actual Study Start Date :

Jun 23, 2021

Anticipated Primary Completion Date :

Nov 23, 2022

Anticipated Study Completion Date :

Dec 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Polynucleotides-based therapy improves genitourinary syndrome of menopause. A pilot study At the request of the hospital ethics committee, a first pilot study was carried out, where 30 participants with the diagnosis of genitourinary syndrome were recruited from the "climacteric and bone metabolism clinic of the Regional Hospital October 1st-ISSSTE" . 15 participants were non-randomly assigned to the control group, receiving local estrogen-based therapy and the other 15 participants were assigned to the experimental group, receiving local polynucleotide-based therapy. Both groups were evaluated initially and a follow-up evaluation was performed at 3 months.	Drug: 3 g Polynucleotide vaginal suppositories 3 g polynucleotide vaginal suppositories were administered nightly for 6 days. Other Names: Tunover® Drug: Conjugated estrogens cream 1g Tube Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months. Other Names: Generic
Experimental: Polynucleotides-based therapy improves genitourinary syndrome of menopause. Randomized control trial After completing the pilot study, it was possible to continue with the work with the approval of the ethics committee, thereby a randomized clinical trial is being carried out. In this arm, 120 participants of the "climacteric and bone metabolism clinic of the Regional Hospital October 1st-ISSSTE" with the diagnosis of genitourinary syndrome of menopause will be enrolled . 60 patients will be randomly assigned to a control group that will receive local estrogen-based therapy, while the other 60 participants will receive local polynucleotide-based therapy. An initial evaluation will be carried out, as well as another follow-up at 3 months.	Drug: 3 g Polynucleotide vaginal suppositories 3 g polynucleotide vaginal suppositories were administered nightly for 6 days. Other Names: Tunover® Drug: Conjugated estrogens cream 1g Tube Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months. Other Names: Generic

Arm

Intervention/Treatment

Experimental: Polynucleotides-based therapy improves genitourinary syndrome of menopause. A pilot study

At the request of the hospital ethics committee, a first pilot study was carried out, where 30 participants with the diagnosis of genitourinary syndrome were recruited from the "climacteric and bone metabolism clinic of the Regional Hospital October 1st-ISSSTE" . 15 participants were non-randomly assigned to the control group, receiving local estrogen-based therapy and the other 15 participants were assigned to the experimental group, receiving local polynucleotide-based therapy. Both groups were evaluated initially and a follow-up evaluation was performed at 3 months.

Drug: 3 g Polynucleotide vaginal suppositories

3 g polynucleotide vaginal suppositories were administered nightly for 6 days.

Other Names:

Tunover®

Drug: Conjugated estrogens cream 1g Tube

Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months.

Other Names:

Generic

Experimental: Polynucleotides-based therapy improves genitourinary syndrome of menopause. Randomized control trial

After completing the pilot study, it was possible to continue with the work with the approval of the ethics committee, thereby a randomized clinical trial is being carried out. In this arm, 120 participants of the "climacteric and bone metabolism clinic of the Regional Hospital October 1st-ISSSTE" with the diagnosis of genitourinary syndrome of menopause will be enrolled . 60 patients will be randomly assigned to a control group that will receive local estrogen-based therapy, while the other 60 participants will receive local polynucleotide-based therapy. An initial evaluation will be carried out, as well as another follow-up at 3 months.

Drug: 3 g Polynucleotide vaginal suppositories

3 g polynucleotide vaginal suppositories were administered nightly for 6 days.

Other Names:

Tunover®

Drug: Conjugated estrogens cream 1g Tube

Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months.

Other Names:

Generic

Outcome Measures

Primary Outcome Measures

Change from baseline Item 9 Menopause Rating Scale (MRS) total score at 3 months [3 months]
Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. Item 9 assesses the severity of sexual problems, including changes in libido, sexual activity, and dyspareunia. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.
Change from baseline Item 10 Menopause Rating Scale (MRS) total score at 3 months [3 months]
Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. Item 10 assesses the severity of urinary problems such as polyuria, urinary urgency, bladder instability, and urinary incontinence. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.
Change from baseline Item 11 Menopause Rating Scale (MRS) total score at 3 months [3 months]
Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. Item 11 assesses the severity of vaginal dryness. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.
Change from baseline Vaginal Maturity Index (VMI) at 3 months [3 months]
The vaginal maturation index (VMI) is used to assess the hormonal status of the vaginal epithelium, which quantifies the proportions of cell types in the vaginal epithelium. The VMI was evaluated through vaginal cytology, where the percentage of basal/parabasal, intermediate and superficial cells were calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of Genitourinary Syndrome of Menopause that presents an MRS > 5 in the urogenital domain, with alterations in the vaginal maturity index (VMI) and in the vaginal pH

Exclusion Criteria:

Incomplete clinical records or clinical records.
Age over 70 years.
Diagnosis of secondary (hereditary) osteoporosis.
History of prolonged use of steroids.
Lack of adherence to medical treatment.
Diagnosis of cancer.
Diagnosis of depression.
Diagnosis of Celiac disease or with the presence of alterations in intestinal absorption.
Allergies to any of the medications administered.