Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women

What this trial studies

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.

Conditions in scope

• Vulvovaginal Atrophy
• Genitourinary Syndrome of Menopause

Interventions

• vaginal estradiol 10 μg (Drug) — Vagifem® (estradiol), vaginal tablets
• vaginal DHEA 6.5 mg (Drug) — Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries

Who can join

Women only · Ages 40 Years to 80 Years

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.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE4
• Start date: 2020-12-18
• Primary completion: 2024-12-15
• Last update posted: 2024-12-17
• First posted: 2022-10-19

Sponsor & contact

Lead sponsor: Angelica Lindén Hirschberg (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Dyspareunia, a symptom of VVA in postmenopausal women (Primary endpoint will be evaluated as change in dyspareunia (VASQ section 1) from baseline to Week 12)
  Patient reports in the Vaginal Atrophy Symptoms Questionnaire (VASQ, section 1). A 4-point scale, where a higher point means more symptoms.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.