Phase 4
N=50
Treating Postmenopausal Dyspareunia Where it Hurts
Dyspareunia
Bottom Line
View on ClinicalTrials.gov: NCT03240081 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug — -1.5; -3 score on a scale — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 50mcg estradiol cream (Drug); 100mcg estradiol cream (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Oregon Health and Science University
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug |
-1.5; -3 | 0.08 |
| PRIMARY Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug |
-4; -5.5 | 0.95 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03240081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.