Treating Postmenopausal Dyspareunia Where it Hurts

NCT03240081 | Completed Phase 4 Results FDA Drug

• 1 other identifier: OHSU IRB 16770
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspareunia

Keywords

Post-menopause dyspareunia; Vulvar vestibular pain; Genitourinary syndrome of menopause; Sexual pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 12 weeks

Study Arms (2)

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

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

Drug: 100mcg estradiol cream

Interventions

50mcg estradiol cream DRUG

Use of study drug nightly applied to vulvar vestibule

50mcg estradiol cream

100mcg estradiol cream DRUG

Use of study drug nightly

100mcg estradiol cream

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science Univerity

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• 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.

  PMID: 36787525 DERIVED

• 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.

  PMID: 35231008 DERIVED

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Limitations and Caveats

The design did not include a placebo arm. Therefore the various minor "adverse events" or side effects that were tabulated cannot be compared to the same complaints in a placebo arm. "Adverse events" includes specific possible estrogen side effects which were queried in repeating questionnaires rather than being volunteered by participants.

Results Point of Contact

• Title: Dr. Martha Goetsch
• Organization: OHSU

goetsch@ohsu.edu

503-494-3666

Study Officials

• Martha Goetsch, MD, MPH

  Oregon Health & Science University, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 4, 2017
• Study Start: June 20, 2017
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: May 22, 2023
• Results First Posted: January 20, 2021

Record last verified: 2023-05

Locations

US (1)