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Treating Postmenopausal Dyspareunia Where it Hurts

Primary Purpose

Dyspareunia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

50mcg estradiol cream

100mcg estradiol cream

About this trial

This is an interventional treatment trial for Dyspareunia focused on measuring Post-menopause dyspareunia, Vulvar vestibular pain, Genitourinary syndrome of menopause, Sexual pain

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Oregon Health & Science Univerity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

50mcg estradiol cream

100mcg estradiol cream

Arm Description

Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump

Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03240081

First Posted

August 2, 2017

Last Updated

May 18, 2023

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT03240081

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

June 20, 2017 (Actual)

Primary Completion Date

November 21, 2019 (Actual)

Study Completion Date

November 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyspareunia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double Blind

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50mcg estradiol cream

Arm Type

Active Comparator

Arm Description

Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump

Arm Title

100mcg estradiol cream

Arm Type

Active Comparator

Arm Description

Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump

Intervention Type

Drug

Intervention Name(s)

50mcg estradiol cream

Intervention Description

Use of study drug nightly applied to vulvar vestibule

Intervention Type

Drug

Intervention Name(s)

100mcg estradiol cream

Intervention Description

Use of study drug nightly

Primary Outcome Measure Information:

Title

Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug

Description

Time Frame

Baseline to 4 weeks

Title

Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug

Description

Time Frame

Baseline and 12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martha Goetsch, MD, MPH

Organizational Affiliation

Oregon Health & Science University, Portland, OR

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health & Science Univerity

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35231008

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.

Results Reference

derived

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Treating Postmenopausal Dyspareunia Where it Hurts

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