Treating Postmenopausal Dyspareunia Where it Hurts

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2019-11-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis

NCT00816556

Atrophic Vaginitis

TERMINATED PHASE3

Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women

NCT02253173

Vulvovaginal Atrophy Menopause Dyspareunia +1 more

COMPLETED PHASE3

Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

NCT04232813

Vulvovaginal Atrophy

COMPLETED PHASE3

Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia

NCT01845649

Vulvovaginal Atrophy

COMPLETED PHASE3

A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women

NCT02859285

Hypoactive Sexual Desire Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyspareunia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double Blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

50mcg estradiol cream

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

Group Type ACTIVE_COMPARATOR

50mcg estradiol cream

Intervention Type DRUG

Use of study drug nightly applied to vulvar vestibule

100mcg estradiol cream

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

Group Type ACTIVE_COMPARATOR

100mcg estradiol cream

Intervention Type DRUG

Use of study drug nightly

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

50mcg estradiol cream

Use of study drug nightly applied to vulvar vestibule

Intervention Type DRUG

100mcg estradiol cream

Use of study drug nightly

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes