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NCT Number: NCT05586711

Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women

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.

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Key information

Conditions

Vulvovaginal Atrophy Genitourinary Syndrome of Menopause

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Karolinska University Hospital

Stockholm, 171 76, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vaginal estradiol 10 μg

Drug

Vagifem® (estradiol), vaginal tablets

vaginal DHEA 6.5 mg

Drug

Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries

Primary outcomes

  1. Dyspareunia, a symptom of VVA in postmenopausal women

    Time frame: 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.

Secondary outcomes

  1. Total symptom score of VVA

    Time frame: Change from baseline to Week 4 and 12

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

  2. Clinical signs of VVA

    Time frame: Change from baseline to Week 4 and 12

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

  3. Sexual function

    Time frame: Change from baseline to Week 4 and 12

    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)

  4. Urinary incontinence

    Time frame: Change from baseline to Week 4 and 12

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

  5. Histomorphology of the vaginal wall

    Time frame: Change from baseline to Week 4 and 12

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

  6. Sex hormone levels

    Time frame: Change from baseline to Week 4 and 12

    Sex hormone levels (estradiol and testosterone)

Other outcomes

  1. Sexual activity

    Time frame: Change from baseline to Week 4 and 12

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

  2. Sexual distress

    Time frame: Change from baseline to Week 4 and 12

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

  3. Urogenital distress

    Time frame: Change from baseline to Week 4 and 12

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

Sponsors and collaborators

Lead sponsor

Angelica Lindén Hirschberg

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2022
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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