Trial Outcomes & Findings for Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function (NCT NCT03493126)

Results Overview

The VUAS is a four-item measurement administered by a clinical provider that quantifies and rates the patient's responses to questions of dryness, soreness, irritation and pain to external stimulation. Patients are asked whether they have experienced specific symptoms ("yes/no") during the past 4 weeks and rate symptom severity ("none," "mild," "moderate," "severe"). The first 3 items assess dryness, soreness, and irritation during routine activities excluding sexual intercourse and the fourth item assesses pain with external manual stimulation. An option for "no attempt" indicates a patient has not been sexually active within the past 4 weeks. Each item in the VuAS is scored from 0 (none) to 3 (severe) with composite scores calculated by taking the mean of the items when at least two of four items are not missing. Higher scores indicate worse symptoms. The minimum composite score is 0 and maximum composite score is 3.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

59 participants

Primary outcome timeframe

3 months

Results posted on

2021-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Estradiol Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Estradiol: 17β-estradiol vaginal cream	Placebo Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Placebo: Compounded placebo cream
Overall Study STARTED	31	28
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

no difference in

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Estradiol n=31 Participants Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Estradiol: 17β-estradiol vaginal cream	Placebo n=28 Participants Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Placebo: Compounded placebo cream	Total n=59 Participants Total of all reporting groups
Age, Continuous	29.3 years STANDARD_DEVIATION 5.1 • n=5 Participants	28.0 years STANDARD_DEVIATION 4.1 • n=7 Participants	28.6 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	28 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White non-hispanic	26 Participants n=5 Participants • no difference in	18 Participants n=7 Participants • no difference in	44 Participants n=5 Participants • no difference in
Race/Ethnicity, Customized Race/Ethnicity · Black non-hispanic	2 Participants n=5 Participants • no difference in	3 Participants n=7 Participants • no difference in	5 Participants n=5 Participants • no difference in
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	1 Participants n=5 Participants • no difference in	5 Participants n=7 Participants • no difference in	6 Participants n=5 Participants • no difference in
Race/Ethnicity, Customized Race/Ethnicity · Other race/ethnicity	2 Participants n=5 Participants • no difference in	1 Participants n=7 Participants • no difference in	3 Participants n=5 Participants • no difference in
Race/Ethnicity, Customized Race/Ethnicity · missing	0 Participants n=5 Participants • no difference in	1 Participants n=7 Participants • no difference in	1 Participants n=5 Participants • no difference in

PRIMARY outcome

Timeframe: 3 months

The VUAS is a four-item measurement administered by a clinical provider that quantifies and rates the patient's responses to questions of dryness, soreness, irritation and pain to external stimulation. Patients are asked whether they have experienced specific symptoms ("yes/no") during the past 4 weeks and rate symptom severity ("none," "mild," "moderate," "severe"). The first 3 items assess dryness, soreness, and irritation during routine activities excluding sexual intercourse and the fourth item assesses pain with external manual stimulation. An option for "no attempt" indicates a patient has not been sexually active within the past 4 weeks. Each item in the VuAS is scored from 0 (none) to 3 (severe) with composite scores calculated by taking the mean of the items when at least two of four items are not missing. Higher scores indicate worse symptoms. The minimum composite score is 0 and maximum composite score is 3.

Outcome measures

Outcome measures
Measure	Estradiol n=31 Participants Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Estradiol: 17β-estradiol vaginal cream	Placebo n=28 Participants Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Placebo: Compounded placebo cream
Vulvar Assessment Scale (VUAS)	0.10 score on a scale Standard Deviation 0.25	0.20 score on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: 3 months

Edinburgh Postnatal Depression Scale (EPDS) The EPDS is a validated 10-question depression assessment for postpartum women, which includes anxiety symptoms and excludes constitutional symptoms associated with depression common in the postpartum period, such as changes in sleeping patterns. Questions 1, 2, \& 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3 and 5--10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Minimum total score: 0 Maximum total score: 30. Total score of 10 or higher may be indicative of postpartum depression.

Outcome measures

Outcome measures
Measure	Estradiol n=31 Participants Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Estradiol: 17β-estradiol vaginal cream	Placebo n=28 Participants Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Placebo: Compounded placebo cream
Depression	4.07 score on a scale Standard Deviation 3.71	4.07 score on a scale Standard Deviation 2.99

SECONDARY outcome

Timeframe: 3 months

Urinary Distress Inventory (UDI-6) The UDI-6 is a questionnaire that includes 6 items evaluating bother from urinary symptoms with higher scores indicating more disability. Each item is scored from 0-3. The total score is the average individual score multiplied by 25. The minimal score is 0 and maximum score is 100.

Outcome measures

Outcome measures
Measure	Estradiol n=31 Participants Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Estradiol: 17β-estradiol vaginal cream	Placebo n=28 Participants Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Placebo: Compounded placebo cream
Urinary Symptoms	5.6 score on a scale Standard Deviation 10.2	10.5 score on a scale Standard Deviation 23.5

SECONDARY outcome

Timeframe: 3 months

Fecal Incontinence Severity Index (FISI) for bowel symptoms The FISI evaluates patient responses symptom severity to fecal incontinence with higher scores indicating more bothersome anal incontinence symptoms. The FISI score ranges from 0 to 61 with higher score indicating higher severity of the fecal incontinence.

Outcome measures

Outcome measures
Measure	Estradiol n=31 Participants Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Estradiol: 17β-estradiol vaginal cream	Placebo n=28 Participants Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Placebo: Compounded placebo cream
Fecal Incontinence	16.5 score on a scale Standard Deviation 14.3	15.4 score on a scale Standard Deviation 12.4

SECONDARY outcome

Timeframe: 3 months

Female Sexual Function Index (FSFI) The FSFI is a validated questionnaire to assess sexual function in six domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain over the 4 weeks prior to administration of questionnaire with lower scores indicating more sexual dysfunction. The FSFI score ranges from 2-36 with LOWER score indicating worse sexual dysfunction.

Outcome measures

Outcome measures
Measure	Estradiol n=31 Participants Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Estradiol: 17β-estradiol vaginal cream	Placebo n=28 Participants Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Placebo: Compounded placebo cream
Sexual Function	25.4 score on a scale Standard Deviation 8.1	20.5 score on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: 3 months

Likert scale Satisfaction will be assessed using the patient satisfaction questionnaire in response to the question, "How satisfied were you with your progress with this treatment?"

Outcome measures

Outcome measures
Measure	Estradiol n=27 Participants Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Estradiol: 17β-estradiol vaginal cream	Placebo n=27 Participants Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Placebo: Compounded placebo cream
Satisfaction Via Likert Scale Very satisfied	14 Participants	9 Participants
Satisfaction Via Likert Scale Somewhat satisfied	5 Participants	6 Participants
Satisfaction Via Likert Scale Neutral/unsure	8 Participants	11 Participants
Satisfaction Via Likert Scale somewhat dissatisfied	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months

At each clinical/research visit the participant will be asked about any adverse events (AEs). AEs will be reported with study outcomes.

Outcome measures

Outcome measures
Measure	Estradiol n=31 Participants Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Estradiol: 17β-estradiol vaginal cream	Placebo n=28 Participants Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum. Placebo: Compounded placebo cream
Adverse Outcomes	0 Participants	1 Participants

Adverse Events

Estradiol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew Hundley

The Ohio State University

Phone: 614-293-4647

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place