Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women

NCT ID: NCT05586711

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2024-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vaginal estradiol 10 μg

Group Type: ACTIVE_COMPARATOR

vaginal estradiol 10 μg

Intervention Type: DRUG

Vagifem® (estradiol), vaginal tablets

Vaginal DHEA 6,5 mg

Group Type: ACTIVE_COMPARATOR

vaginal DHEA 6.5 mg

Intervention Type: DRUG

Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries

Interventions

vaginal estradiol 10 μg

Vagifem® (estradiol), vaginal tablets

Intervention Type: DRUG

vaginal DHEA 6.5 mg

Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Angelica Lindén Hirschberg

OTHER

Sponsor Role: lead

Responsible Party

Angelica Lindén Hirschberg

Professor, MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2020-003254-76

Identifier Type: -

Identifier Source: org_study_id