Trial Outcomes & Findings for Treating Postmenopausal Dyspareunia Where it Hurts (NCT NCT03240081)

Last Updated: 2023-05-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

Baseline to 4 weeks

Results posted on

2023-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	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 50mcg estradiol cream: Use of study drug nightly	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 100mcg estradiol cream: Use of study drug nightly
Overall Study STARTED	25	25
Overall Study COMPLETED	25	22
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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 50mcg estradiol cream: Use of study drug nightly	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 100mcg estradiol cream: Use of study drug nightly
Overall Study Withdrawal by Subject	0	2
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

One was not analyzed because she was found to have a disqualifying diagnosis after the trial had commenced 1 mo.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to 4 weeks

Outcome measures

Outcome measures
Measure	50mcg Estradiol Cream n=25 Participants Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump 50mcg estradiol cream: Use of study drug nightly	100mcg Estradiol Cream n=22 Participants Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump 100mcg estradiol cream: Use of study drug nightly
Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug	-1.5 score on a scale Interval -2.0 to -1.0	-3 score on a scale Interval -5.0 to -2.0

PRIMARY outcome

Timeframe: Baseline and 12 weeks

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.

Outcome measures

Outcome measures
Measure	50mcg Estradiol Cream n=25 Participants Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump 50mcg estradiol cream: Use of study drug nightly	100mcg Estradiol Cream n=22 Participants Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump 100mcg estradiol cream: Use of study drug nightly
Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug	-4 score on a scale Interval -6.0 to -3.0	-5.5 score on a scale Interval -6.0 to -4.5

Adverse Events

50mcg Estradiol Cream

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

100mcg Estradiol Cream

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	50mcg Estradiol Cream n=25 participants at risk Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump 50mcg estradiol cream: Use of study drug nightly	100mcg Estradiol Cream n=25 participants at risk Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump 100mcg estradiol cream: Use of study drug nightly
Reproductive system and breast disorders mastalgia	20.0% 5/25 • Number of events 7 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.	12.0% 3/25 • Number of events 3 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.
Nervous system disorders increased headaches	16.0% 4/25 • Number of events 4 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.	16.0% 4/25 • Number of events 4 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.
Endocrine disorders increased hot flashes	32.0% 8/25 • Number of events 9 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.	20.0% 5/25 • Number of events 6 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.
Reproductive system and breast disorders postcoital spotting	8.0% 2/25 • Number of events 2 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.	0.00% 0/25 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.
Skin and subcutaneous tissue disorders local skin irritation	0.00% 0/25 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.	8.0% 2/25 • Number of events 2 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.
General disorders fatigue	0.00% 0/25 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.	8.0% 2/25 • Number of events 2 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.
Respiratory, thoracic and mediastinal disorders URI	0.00% 0/25 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.	12.0% 3/25 • Number of events 3 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.
Reproductive system and breast disorders Candida vaginitis	0.00% 0/25 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.	12.0% 3/25 • Number of events 3 • 3 months We assessed certain symptoms that could be potentially related to the intervention by including relevant questions on a questionnaire administered repeatedly through the intervention period.

Additional Information

Dr. Martha Goetsch

OHSU

Phone: 503-494-3666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	50mcg Estradiol Cream n=25 Participants Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump 50mcg estradiol cream: Use of study drug nightly	100mcg Estradiol Cream n=25 Participants Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump 100mcg estradiol cream: Use of study drug nightly	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=25 Participants	18 Participants n=25 Participants	39 Participants n=50 Participants
Age, Categorical >=65 years	4 Participants n=25 Participants	7 Participants n=25 Participants	11 Participants n=50 Participants
Age, Continuous	59.24 years STANDARD_DEVIATION 6.16 • n=25 Participants	60.17 years STANDARD_DEVIATION 7.7 • n=25 Participants	59.69 years STANDARD_DEVIATION 6.90 • n=50 Participants
Sex: Female, Male Female	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
Sex: Female, Male Male	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants	1 Participants n=25 Participants	1 Participants n=50 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Black or African American	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race (NIH/OMB) White	24 Participants n=25 Participants	24 Participants n=25 Participants	48 Participants n=50 Participants
Race (NIH/OMB) More than one race	1 Participants n=25 Participants	0 Participants n=25 Participants	1 Participants n=50 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Region of Enrollment United States	25 participants n=25 Participants	25 participants n=25 Participants	50 participants n=50 Participants
BMI	24.59 kg/m^2 STANDARD_DEVIATION 4.04 • n=25 Participants • One was not analyzed because she was found to have a disqualifying diagnosis after the trial had commenced 1 mo.	25.91 kg/m^2 STANDARD_DEVIATION 7.7 • n=24 Participants • One was not analyzed because she was found to have a disqualifying diagnosis after the trial had commenced 1 mo.	25.23 kg/m^2 STANDARD_DEVIATION 4.61 • n=49 Participants • One was not analyzed because she was found to have a disqualifying diagnosis after the trial had commenced 1 mo.