Trial · NCT03240081
Treating Postmenopausal Dyspareunia Where it Hurts
NCT03240081, Phase 4, Completed, Oregon Health and Science University; results first posted 2021-01-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treating Postmenopausal Dyspareunia Where it Hurts. Trials, record NCT03240081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03240081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treating Postmenopausal Dyspareunia Where it Hurts
- NCT number
- NCT03240081
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 50 participants, actual
- Lead sponsor
- Oregon Health and Science University
- Conditions
- Dyspareunia
- Interventions
- 50mcg estradiol cream, 100mcg estradiol cream
- First posted
- 2017-08-04
- Last updated
- 2023-05-22
- Results first posted
- 2021-01-20
- 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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug | Baseline to 4 weeks | 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. |
| Primary | Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug | Baseline to 4 weeks | score on a scale | MEDIAN | |
| PRIMARY | Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug | Baseline and 12 weeks | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug | 50mcg Estradiol Cream | -1.5 | Inter-Quartile Range -2 to -1 | score on a scale | |
| Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug | 100mcg Estradiol Cream | -3 | Inter-Quartile Range -5 to -2 | score on a scale | |
| Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug | 50mcg Estradiol Cream | -4 | Inter-Quartile Range -6 to -3 | score on a scale | |
| Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug | 100mcg Estradiol Cream | -5.5 | Inter-Quartile Range -6 to -4.5 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 50mcg Estradiol Cream | 25 | |
| Overall Study | STARTED | 100mcg Estradiol Cream | 25 | |
| Overall Study | COMPLETED | 50mcg Estradiol Cream | 25 | |
| Overall Study | COMPLETED | 100mcg Estradiol Cream | 22 | |
| Overall Study | NOT COMPLETED | 50mcg Estradiol Cream | 0 | |
| Overall Study | NOT COMPLETED | 100mcg Estradiol Cream | 3 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | mastalgia | Reproductive system and breast disorders | 50mcg Estradiol Cream | 5 | 25 | 7 |
| other | mastalgia | Reproductive system and breast disorders | 100mcg Estradiol Cream | 3 | 25 | 3 |
| other | increased headaches | Nervous system disorders | 50mcg Estradiol Cream | 4 | 25 | 4 |
| other | increased headaches | Nervous system disorders | 100mcg Estradiol Cream | 4 | 25 | 4 |
| other | increased hot flashes | Endocrine disorders | 50mcg Estradiol Cream | 8 | 25 | 9 |
| other | increased hot flashes | Endocrine disorders | 100mcg Estradiol Cream | 5 | 25 | 6 |
| other | postcoital spotting | Reproductive system and breast disorders | 50mcg Estradiol Cream | 2 | 25 | 2 |
| other | postcoital spotting | Reproductive system and breast disorders | 100mcg Estradiol Cream | 0 | 25 | 0 |
| other | local skin irritation | Skin and subcutaneous tissue disorders | 50mcg Estradiol Cream | 0 | 25 | 0 |
| other | local skin irritation | Skin and subcutaneous tissue disorders | 100mcg Estradiol Cream | 2 | 25 | 2 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 50mcg Estradiol Cream | 0 | 25 |
| Total, all-cause mortality | 100mcg Estradiol Cream | 0 | 25 |
| Total, other adverse events | 50mcg Estradiol Cream | 13 | 25 |
| Total, other adverse events | 100mcg Estradiol Cream | 6 | 25 |
| Total, serious adverse events | 50mcg Estradiol Cream | 0 | 25 |
| Total, serious adverse events | 100mcg Estradiol Cream | 0 | 25 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 50mcg Estradiol Cream vs 100mcg Estradiol Cream: deaths from any cause | Trial comparisons |
| 50mcg Estradiol Cream vs 100mcg Estradiol Cream: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03240081
GET https://conductscience.org/api/trials/v1/NCT03240081/registered