Status:
COMPLETED
Treating Postmenopausal Dyspareunia Where it Hurts
Lead Sponsor:
Oregon Health and Science University
Conditions:
Dyspareunia
Eligibility:
FEMALE
40-70 years
Phase:
PHASE4
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 postmen...
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 a...
Eligibility Criteria
Inclusion
- Postmenopausal women aged 40 to 70 years old.
- 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.
- 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.\*
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03240081
Start Date
June 20 2017
End Date
November 21 2019
Last Update
May 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oregon Health & Science Univerity
Portland, Oregon, United States, 97239