DyspareuniaPhase 4NCT03240081
Treating Postmenopausal Dyspareunia Where it Hurts
A Phase 4 study testing 50mcg estradiol cream and 100mcg estradiol cream in people with Dyspareunia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two low doses of estrogen cream applied to a new location for the treatment of moderate or severe pain during sexual intercourse in postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dyspareunia
- What is being tested?
- 50mcg estradiol cream and 100mcg estradiol cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2017to 21 Nov 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged 40 to 70 years old.
- Postmenopausal, demonstrated by at least one of the following:
- Cessation of menses for ≥1 years if age is >50 ii. Bilateral oophorectomy iii. A history of climacteric symptoms if below age 50, having an ovary and scarred or absent uterus.
- Onset of dyspareunia after menopause.*
- Stable heterosexual partnership ≥2 years (or by investigator discretion if less than 2 years) and both partners want to have more satisfying penetrative intimacy.
- No estrogen product use, local or systemic, for 6 months.*
Show all 11Show fewer
- More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).*
- Willingness to enter a study where she will receive low-dose local estrogen.*
- Willingness to enter a study that requires application of cream on a frequent schedule for 3 months. *
- Willingness to evaluate the progress of therapies by use of the Tampon Test as many as 2 times per week, and willingness to attempt intercourse if the Tampon Test indicates tolerable penetrative pain.*
- n/a for reference group
Who cannot join
- Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
- Negative cotton-swab touch test in the vulvar vestibule or vestibular tenderness that is not extinguishable by application of lidocaine 4% topical solution applied for 3 minutes.
- Partner with sexual dysfunction limiting his performance or making it inconsistent. (The use of male therapy for erectile dysfunction is acceptable.)
- Diagnosis by a physical therapist or clinician of significant pelvic floor muscle tension causing pain (pelvic floor myalgia) or has been found on screening examination to have pelvic floor tenderness or bladder tenderness.
- Constant burning pain localized to the vulva.
- Allergy to local estrogen products or lidocaine numbing agents.
- Previous estrogen receptor positive breast cancer or endometrial cancer.
- Endometrial thickness ≥5mm on screening via transvaginal ultrasound.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science Univerity
Portland, Oregon, 97239
About this study
Official title: Treating Where it Hurts: A Randomized Blinded Clinical Trial of Local Estrogen to the Vulvar Vestibule for Dyspareunia in Postmenopausal Women
The purpose of this study is to compare the effectiveness of two low doses of estrogen cream applied to a new location for the treatment of moderate or severe pain during sexual intercourse in postmenopausal women.
Read the detailed description
Estrogen cream is FDA-approved for vaginal use for the treatment of sexual pain, but its use in a new location is experimental. Pain with sex is a common problem experienced by women after menopause and the relationship of pain to sexual difficulties is well established. The cause has been assumed to be atrophy and the location has been assumed to be the vagina. Recent focused studies have shown that the location of pain is the vulvar vestibule and usually not the vagina. This study will look at pain before and after therapy with estrogen when only the vulvar entryway area is treated. This will be a study focused on sexual dysfunction in postmenopausal women.
- Conditions
- Dyspareunia
- Being tested
- 50mcg estradiol cream, 100mcg estradiol cream
- Keywords
- Post-menopause dyspareunia, Vulvar vestibular pain, Genitourinary syndrome of menopause, Sexual pain
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50mcg estradiol creamDrug
Use of study drug nightly applied to vulvar vestibule
100mcg estradiol creamDrug
Use of study drug nightly
| Study group | Role | What they receive |
|---|---|---|
| 50mcg estradiol cream | Active comparator | Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump Receives: Drug: 50mcg estradiol cream |
| 100mcg estradiol cream | Active comparator | Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump Receives: Drug: 100mcg estradiol cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug
Change in median dyspareunia pain scores between baseline and 4 weeks of use of nightly use of study medication. Pain will be assessed using 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst possible pain.
Measured: Baseline to 4 weeks
Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug
Difference in median dyspareunia pain scores between arms for intercourse at 12 weeks after use of nightly study medication for 90d. Pain will be assessed using 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst possible pain.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start20 Jun 2017
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyspareuniaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Jensen, Oregon Health and Science University
- Investigators
- Martha Goetsch, MD, MPH, Principal investigator, Oregon Health & Science University, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240081
- Sponsor's protocol ID
- OHSU IRB 16770
- Status last verified
- May 2023
- First submitted
- 2 Aug 2017
- Last updated
- 22 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Goetsch MF, Garg B, Lillemon J, Clark AL. Treating where it hurts-a randomized comparative trial of vestibule estradiol for postmenopausal dyspareunia. Menopause. 2023 May 1;30(5):467-475. doi: 10.1097/GME.0000000000002162. Epub 2023 Feb 14.
PubMed 36787525Goetsch MF, Garg B, Lillemon J, Clark AL. Where does postmenopausal dyspareunia hurt? A cross-sectional report. Menopause. 2022 Jun 1;29(6):646-653. doi: 10.1097/GME.0000000000001956.
PubMed 35231008
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Where it Hurts: A Randomized Blinded Clinical Trial of Local Estrogen to the Vulvar Vestibule for Dyspareunia in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03240081
- Acronym / sponsor ID
- OHSU IRB 16770
- Conditions
- Dyspareunia
- Keywords
- Post-menopause dyspareunia, Vulvar vestibular pain, Genitourinary syndrome of menopause, Sexual pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Posted 20 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of two low doses of estrogen cream applied to a new location for the treatment of moderate or severe pain during sexual intercourse in postmenopausal women.
Detailed description
Estrogen cream is FDA-approved for vaginal use for the treatment of sexual pain, but its use in a new location is experimental. Pain with sex is a common problem experienced by women after menopause and the relationship of pain to sexual difficulties is well established. The cause has been assumed to be atrophy and the location has been assumed to be the vagina. Recent focused studies have shown that the location of pain is the vulvar vestibule and usually not the vagina. This study will look at pain before and after therapy with estrogen when only the vulvar entryway area is treated. This will be a study focused on sexual dysfunction in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50mcg estradiol cream | Active comparator | Drug: 50mcg estradiol creamSubjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump |
| 100mcg estradiol cream | Active comparator | Drug: 100mcg estradiol creamSubjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Postmenopausal women aged 40 to 70 years old.
- Postmenopausal, demonstrated by at least one of the following:
- Onset of dyspareunia after menopause.*
- Stable heterosexual partnership ≥2 years (or by investigator discretion if less than 2 years) and both partners want to have more satisfying penetrative intimacy.
- No estrogen product use, local or systemic, for 6 months.*
Key exclusion criteria (8 listed)
- Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
- Negative cotton-swab touch test in the vulvar vestibule or vestibular tenderness that is not extinguishable by application of lidocaine 4% topical solution applied for 3 minutes.
- Partner with sexual dysfunction limiting his performance or making it inconsistent. (The use of male therapy for erectile dysfunction is acceptable.)
- Diagnosis by a physical therapist or clinician of significant pelvic floor muscle tension causing pain (pelvic floor myalgia) or has been found on screening examination to have pelvic floor tenderness or bladder tenderness.
- Constant burning pain localized to the vulva.
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 |
|---|---|---|
| 50mcg estradiol creamUse of study drug nightly applied to vulvar vestibule | Drug | 50mcg estradiol cream |
| 100mcg estradiol creamUse of study drug nightly | Drug | 100mcg estradiol cream |
Primary outcome
Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug
Time frame: Baseline to 4 weeks
Change in median dyspareunia pain scores between baseline and 4 weeks of use of nightly use of study medication. Pain will be assessed using 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst possible pain.
Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug
Time frame: Baseline and 12 weeks
Difference in median dyspareunia pain scores between arms for intercourse at 12 weeks after use of nightly study medication for 90d. Pain will be assessed using 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst possible pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36787525Goetsch MF, Garg B, Lillemon J, Clark AL. Treating where it hurts-a randomized comparative trial of vestibule estradiol for postmenopausal dyspareunia. Menopause. 2023 May 1;30(5):467-475. doi: 10.1097/GME.0000000000002162. Epub 2023 Feb 14.
- Derived from this study: PubMed 35231008Goetsch MF, Garg B, Lillemon J, Clark AL. Where does postmenopausal dyspareunia hurt? A cross-sectional report. Menopause. 2022 Jun 1;29(6):646-653. doi: 10.1097/GME.0000000000001956.
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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.
Martha Goetsch, MD, MPH principal investigator
Oregon Health & Science University, Portland, OR
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 50mcg estradiol cream and 100mcg estradiol cream in people with Dyspareunia, run by Oregon Health and Science University at 1 site in United States.
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 11 inclusion and 8 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 22 May 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug (time frame: Baseline to 4 weeks). The study lists 2 primary outcomes in all. 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 NCT03240081, which also lists 2 linked publications.
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 22 May 2023.