Vulvovaginal AtrophyPhase 4NCT05586711
Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women
A Phase 4 study testing vaginal estradiol 10 μg and vaginal DHEA 6.5 mg in people with Vulvovaginal Atrophy and Genitourinary Syndrome of Menopause, run by Angelica Lindén Hirschberg at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Vulvovaginal Atrophy, Genitourinary Syndrome of Menopause
- What is being tested?
- vaginal estradiol 10 μg and vaginal DHEA 6.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSweden
- Study dates
- 18 Dec 2020to 15 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- vaginal estradiol 10 μg, vaginal DHEA 6.5 mg
- Keywords
- Vulvovaginal atrophy, Genitourinary Syndrome of Menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal estradiol 10 μgDrug
Vagifem® (estradiol), vaginal tablets
vaginal DHEA 6.5 mgDrug
Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries
| Study group | Role | What they receive |
|---|---|---|
| Vaginal estradiol 10 μg | Active comparator | Not described Receives: Drug: vaginal estradiol 10 μg |
| Vaginal DHEA 6,5 mg | Active comparator | Not described Receives: Drug: vaginal DHEA 6.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Vaginal dryness and irritation/itching (VASQ, section 2 and 3, a 4-point scale, where a higher point means more symptoms)
Measured: Change from baseline to Week 4 and 12
Clinical signs of VVA
Examination of vaginal atrophy symptoms (VAX). A 4-point scale, where a higher point means more symptoms.
Measured: Change from baseline to Week 4 and 12
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)
Measured: Change from baseline to Week 4 and 12
Urinary incontinence
The Incontinence Impact Questionnaire (IIQ-7, a 4-point scale, where a higher point means more symptoms)
Measured: Change from baseline to Week 4 and 12
Histomorphology of the vaginal wall
Histomorphology (thickness of epithelium, lamina propria and muscle layer in vaginal biopsies)
Measured: Change from baseline to Week 4 and 12
Sex hormone levels
Sex hormone levels (estradiol and testosterone)
Measured: Change from baseline to Week 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start18 Dec 2020
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvovaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angelica Lindén Hirschberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Angelica Lindén Hirschberg, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586711
- Sponsor's protocol ID
- 2020-003254-76
- Status last verified
- Dec 2024
- First submitted
- 9 Oct 2022
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Strandberg M, Cockin A, Hirschberg AL. Effects of vaginal dehydroepiandrosterone and estradiol on dyspareunia, a symptom of vulvovaginal atrophy in postmenopausal women - a randomized controlled trial. Maturitas. 2026 May;208:108924. doi: 10.1016/j.maturitas.2026.108924. Epub 2026 Mar 20.
PubMed 41903372
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05586711
- Acronym / sponsor ID
- 2020-003254-76
- Keywords
- Vulvovaginal atrophy, Genitourinary Syndrome of Menopause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Angelica Lindén HirschbergUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal estradiol 10 μg | Active comparator | Drug: vaginal estradiol 10 μg |
| Vaginal DHEA 6,5 mg | Active comparator | Drug: vaginal DHEA 6.5 mg |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal estradiol 10 μgVagifem® (estradiol), vaginal tablets | Drug | Vaginal estradiol 10 μg |
| vaginal DHEA 6.5 mgIntrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries | Drug | Vaginal DHEA 6,5 mg |
Primary outcome
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.
6 secondary outcomes
Total symptom score of VVA
Time frame: Change from baseline to Week 4 and 12
Clinical signs of VVA
Time frame: Change from baseline to Week 4 and 12
Sexual function
Time frame: Change from baseline to Week 4 and 12
Urinary incontinence
Time frame: Change from baseline to Week 4 and 12
Histomorphology of the vaginal wall
Time frame: Change from baseline to Week 4 and 12
Sex hormone levels
Time frame: Change from baseline to Week 4 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 41903372Strandberg M, Cockin A, Hirschberg AL. Effects of vaginal dehydroepiandrosterone and estradiol on dyspareunia, a symptom of vulvovaginal atrophy in postmenopausal women - a randomized controlled trial. Maturitas. 2026 May;208:108924. doi: 10.1016/j.maturitas.2026.108924. Epub 2026 Mar 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vaginal estradiol 10 μg and vaginal DHEA 6.5 mg in people with Vulvovaginal Atrophy and Genitourinary Syndrome of Menopause, run by Angelica Lindén Hirschberg at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05586711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.