Clinical trial NCT03240081: Treating Postmenopausal Dyspareunia Where it Hurts
Official title: Treating Where it Hurts: A Randomized Blinded Clinical Trial of Local Estrogen to the Vulvar Vestibule for Dyspareunia in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyspareunia
Keywords: Post-menopause dyspareunia
Vulvar vestibular pain
Genitourinary syndrome of menopause
Sexual pain
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Postmenopausal women aged 40 to 70 years old.
2. Postmenopausal, demonstrated by at least one of the following:

   i. 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.
3. Onset of dyspareunia after menopause.\*
4. Stable heterosexual partnership ≥2 years (or by investigator discretion if less than 2 years) and both partners want to have more satisfying penetrative intimacy.
5. No estrogen product use, local or systemic, for 6 months.\*
6. More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).\*
7. Willingness to enter a study where she will receive low-dose local estrogen.\*
8. Willingness to enter a study that requires application of cream on a frequent schedule for 3 months. \*
9. 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

Exclusion Criteria:

1. Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
2. 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.
3. Partner with sexual dysfunction limiting his performance or making it inconsistent. (The use of male therapy for erectile dysfunction is acceptable.)
4. 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.
5. Constant burning pain localized to the vulva.
6. Allergy to local estrogen products or lidocaine numbing agents.
7. Previous estrogen receptor positive breast cancer or endometrial cancer.
8. Endometrial thickness ≥5mm on screening via transvaginal ultrasound.

Primary outcomes:
measure: Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug
timeFrame: Baseline to 4 weeks
measure: Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science Univerity
state: Oregon
Study officials:
affiliation: Oregon Health & Science University, Portland, OR
name: Martha Goetsch, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goetsch 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.