Treating Postmenopausal Dyspareunia Where it Hurts
Condition: Dyspareunia
MeSH terms: Dyspareunia
Intervention: 50mcg estradiol cream; 100mcg estradiol cream
Intervention description: Use of study drug nightly applied to vulvar vestibule; Use of study drug nightly
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double Blind
Enrollment: 50.0
Sex: Female
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Post-menopause dyspareunia; Vulvar vestibular pain; Genitourinary syndrome of menopause; Sexual pain

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:

          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.