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Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women

Primary Purpose

Vulvovaginal Atrophy, Genitourinary Syndrome of Menopause

Status

Recruiting

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

vaginal estradiol 10 μg

vaginal DHEA 6.5 mg

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring Vulvovaginal atrophy, Genitourinary Syndrome of Menopause

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Postmenopausal women (non-hysterectomized or hysterectomized) must satisfy either: a) No menses for at least one year for non-hysterectomized women, or b) Follicle stimulating hormone (FSH) levels >40 IU/L
Women who have self-identified at screening and baseline (Day 1) as experiencing moderate to severe dyspareunia, using VASQ questionnaire (section 1)
Between 40 and 80 years of age
Body mass index (BMI) 19-35
Women having a vaginal pH above 5 at screening and baseline (Day 1)
Women who currently have intercourse or other sexual activity, at least once a month, with a partner
Normal mammogram within 12 months (of Day 1)
A normal PAP smear (which includes inflammatory changes) within the last 12 months (of Day 1) for both non-hysterectomized and hysterectomized women.
Understands Swedish and is willing to participate in the study and sign an informed consent

Exclusion Criteria:

Undiagnosed abnormal vaginal bleeding
Previous diagnosis of cancer, except skin cancer (non-melanoma)
Lichen Sclerosis and other pathological conditions in vulva and/or vagina
Active or history of thromboembolic disease
Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy in the 8 weeks prior to baseline assessments (screening visit)
Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen alone or estrogen/progestin products in the 4 weeks prior to baseline assessments (screening visit)
Use of testosterone or other anabolic steroid within 6 months prior to screening visit
Natural oral estrogenic products in the 4 weeks prior to baseline assessments
Confirmed clinically significant depression (not controlled by standard therapy) or confirmed history of severe psychiatric disturbance
The administration of any investigational drug within 30 days of screening visit

Sites / Locations

Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Vaginal estradiol 10 μg

Vaginal DHEA 6,5 mg

Arm Description

Outcomes

Primary Outcome Measures

Dyspareunia, a symptom of VVA in postmenopausal women

Patient reports in the Vaginal Atrophy Symptoms Questionnaire (VASQ, section 1). A 4-point scale, where a higher point means more symptoms.

Secondary Outcome Measures

Total symptom score of VVA

Vaginal dryness and irritation/itching (VASQ, section 2 and 3, a 4-point scale, where a higher point means more symptoms)

Clinical signs of VVA

Examination of vaginal atrophy symptoms (VAX). A 4-point scale, where a higher point means more symptoms.

Sexual function

Profile of Female Sexual Function (PFSF) and its seven domains desire, arousal, orgasm, pleasure, concern, responsiveness and self-image (range from 0 to 100, where a lower score means more dysfunction)

Urinary incontinence

The Incontinence Impact Questionnaire (IIQ-7, a 4-point scale, where a higher point means more symptoms)

Histomorphology of the vaginal wall

Histomorphology (thickness of epithelium, lamina propria and muscle layer in vaginal biopsies)

Sex hormone levels

Sex hormone levels (estradiol and testosterone)

Full Information

NCT ID

NCT05586711

First Posted

October 9, 2022

Last Updated

October 15, 2022

Sponsor

Angelica Lindén Hirschberg

1. Study Identification

Unique Protocol Identification Number

NCT05586711

Brief Title

Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women

Official Title

Effects of Local Dehydroepiandrosterone (DHEA) and Estradiol on Moderate to Severe Dyspareunia, a Symptom of Vulvovaginal Atrophy in Postmenopausal Women - a Randomized, Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 18, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Angelica Lindén Hirschberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Vulvovaginal atrophy (VVA) is a condition characterized by vaginal dryness, itching, burning, irritation and dyspareunia. The condition is mainly due to estrogen deficiency and is common during and after menopause. Furthermore, androgens may have an important function in these symptoms. The purpose of the study is to compare vaginal estrogen with vaginal dehydroepiandrosterone (DHEA, an androgen precursor) on dyspareunia (primary outcome), a symptom of VVA in postmenopausal women. Secondary outcomes are total symptom score of VVA (vaginal dryness, irritation/itching, maturation index, pH), clinical signs of VVA, sexual function, urogenital symptoms, vaginal histomorphology, sex hormone levels and short-term safety. The hypothesis of the study is that the treatments will have a similar effect on dyspareunia while DHEA, through local androgenic effects (eg growth of muscle tissue and nerve density in the vaginal wall), may be more effective in treating other related symptoms such as sexual dysfunction. 170 postmenopausal women will be randomly assigned to treatment with either vaginal estrogen (Vagifem) or vaginal DHEA (Intrarosa). The women are examined at the start of the study, after 4 weeks of daily application and after another 8 weeks of treatment with twice a week application of the vaginal treatment. The study is expected to provide increased knowledge about the effect of the treatments of VVA in postmenopausal women as well as whether vaginal DHEA has additional positive effects on sexual function compared to vaginal estrogen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vulvovaginal Atrophy, Genitourinary Syndrome of Menopause

Keywords

Vulvovaginal atrophy, Genitourinary Syndrome of Menopause

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vaginal estradiol 10 μg

Arm Type

Active Comparator

Arm Title

Vaginal DHEA 6,5 mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

vaginal estradiol 10 μg

Intervention Description

Vagifem® (estradiol), vaginal tablets

Intervention Type

Drug

Intervention Name(s)

vaginal DHEA 6.5 mg

Intervention Description

Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries

Primary Outcome Measure Information:

Title

Dyspareunia, a symptom of VVA in postmenopausal women

Description

Patient reports in the Vaginal Atrophy Symptoms Questionnaire (VASQ, section 1). A 4-point scale, where a higher point means more symptoms.

Time Frame

Primary endpoint will be evaluated as change in dyspareunia (VASQ section 1) from baseline to Week 12

Secondary Outcome Measure Information:

Title

Total symptom score of VVA

Description

Vaginal dryness and irritation/itching (VASQ, section 2 and 3, a 4-point scale, where a higher point means more symptoms)

Time Frame

Change from baseline to Week 4 and 12

Title

Clinical signs of VVA

Description

Examination of vaginal atrophy symptoms (VAX). A 4-point scale, where a higher point means more symptoms.

Time Frame

Change from baseline to Week 4 and 12

Title

Sexual function

Description

Time Frame

Change from baseline to Week 4 and 12

Title

Urinary incontinence

Description

The Incontinence Impact Questionnaire (IIQ-7, a 4-point scale, where a higher point means more symptoms)

Time Frame

Change from baseline to Week 4 and 12

Title

Histomorphology of the vaginal wall

Description

Histomorphology (thickness of epithelium, lamina propria and muscle layer in vaginal biopsies)

Time Frame

Change from baseline to Week 4 and 12

Title

Sex hormone levels

Description

Sex hormone levels (estradiol and testosterone)

Time Frame

Change from baseline to Week 4 and 12

Other Pre-specified Outcome Measures:

Title

Sexual activity

Description

Sexual activity log (SAL, the number of satisfying sexual episodes over a 1-week period)

Time Frame

Change from baseline to Week 4 and 12

Title

Sexual distress

Description

the Personal Distress Scale (PDS, 0 [no distress] to 100 [maximum distress]).

Time Frame

Change from baseline to Week 4 and 12

Title

Urogenital distress

Description

Urogenital Distress Inventory (UDI-6, a 4-point scale, where a higher point means more symptoms)

Time Frame

Change from baseline to Week 4 and 12

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Postmenopausal women (non-hysterectomized or hysterectomized) must satisfy either: a) No menses for at least one year for non-hysterectomized women, or b) Follicle stimulating hormone (FSH) levels >40 IU/L Women who have self-identified at screening and baseline (Day 1) as experiencing moderate to severe dyspareunia, using VASQ questionnaire (section 1) Between 40 and 80 years of age Body mass index (BMI) 19-35 Women having a vaginal pH above 5 at screening and baseline (Day 1) Women who currently have intercourse or other sexual activity, at least once a month, with a partner Normal mammogram within 12 months (of Day 1) A normal PAP smear (which includes inflammatory changes) within the last 12 months (of Day 1) for both non-hysterectomized and hysterectomized women. Understands Swedish and is willing to participate in the study and sign an informed consent Exclusion Criteria: Undiagnosed abnormal vaginal bleeding Previous diagnosis of cancer, except skin cancer (non-melanoma) Lichen Sclerosis and other pathological conditions in vulva and/or vagina Active or history of thromboembolic disease Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy in the 8 weeks prior to baseline assessments (screening visit) Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen alone or estrogen/progestin products in the 4 weeks prior to baseline assessments (screening visit) Use of testosterone or other anabolic steroid within 6 months prior to screening visit Natural oral estrogenic products in the 4 weeks prior to baseline assessments Confirmed clinically significant depression (not controlled by standard therapy) or confirmed history of severe psychiatric disturbance The administration of any investigational drug within 30 days of screening visit

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Angelica L Hirschberg, MD, PhD

Phone

+46 70 255 99 24

angelica.linden-hirschberg@regionstockholm.se

Facility Information:

Facility Name

Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angelica L Hirschberg, MD, PhD

Phone

+46 70 255 99 24

angelica.linden-hirschberg@regionstockholm.se

First Name & Middle Initial & Last Name & Degree

Moa Strandberg, MD

12. IPD Sharing Statement

Learn more about this trial

Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women

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