Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women

NCT05586711 | Completed Phase 4

• 1 other identifier: 2020-003254-76
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvovaginal Atrophy; Genitourinary Syndrome of Menopause

Keywords

Vulvovaginal atrophy; Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (6)

• Total symptom score of VVA

  Change from baseline to Week 4 and 12

• Clinical signs of VVA

  Change from baseline to Week 4 and 12

• Sexual function

  Change from baseline to Week 4 and 12

• Urinary incontinence

  Change from baseline to Week 4 and 12

• Histomorphology of the vaginal wall

  Change from baseline to Week 4 and 12

Other Outcomes (3)

• Sexual activity

  Change from baseline to Week 4 and 12

• Sexual distress

  Change from baseline to Week 4 and 12

• Urogenital distress

  Change from baseline to Week 4 and 12

Study Arms (2)

Vaginal estradiol 10 μg

ACTIVE COMPARATOR

Drug: vaginal estradiol 10 μg

Vaginal DHEA 6,5 mg

ACTIVE COMPARATOR

Drug: vaginal DHEA 6.5 mg

Interventions

vaginal estradiol 10 μg DRUG

Vagifem® (estradiol), vaginal tablets

Vaginal estradiol 10 μg

vaginal DHEA 6.5 mg DRUG

Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries

Vaginal DHEA 6,5 mg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Angelica Lindén Hirschberg: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 19, 2022
• Study Start: December 18, 2020
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

SE (1)