Trial · NCT02224313
Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women
NCT02224313, Phase 3, Completed, Intira Sriprasert; results first posted 2020-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women. Trials, record NCT02224313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02224313
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women
- NCT number
- NCT02224313
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Intira Sriprasert
- Conditions
- Menopause
- Interventions
- oral estradiol 1.0 mg, oral progesterone 100 mg
- First posted
- 2014-08-25
- Last updated
- 2020-03-19
- Results first posted
- 2020-03-19
- Limitations and caveats
- Several limitations of this study were the small sample size and limited follow-up time, which limited the power to detect statistical significance in some outcomes.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vaginal Cytokines at Baseline | At baseline visit | Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women. |
| Secondary | Vaginal Cytokines During Follow-up | At 14 days and 28 days follow-up | Determine the changes in vaginal cytokines in postmenopausal women following treatment with estradiol then estradiol and progesterone compared to the normal menstrual cycle changes in young premenopausal women. |
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 | Vaginal Cytokines at Baseline | At baseline visit | One postmenopausal women was excluded due to non-compliance of assigned intervention. | pg/ug protein | MEAN |
| SECONDARY | Vaginal Cytokines During Follow-up | At 14 days and 28 days follow-up | Three premenopausal women were excluded due to missing data. | pg/ug protein | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Vaginal Cytokines at Baseline | Premenopausal Women | IL-8 | 2.73 | Standard Deviation 3.67 | pg/ug protein |
| Vaginal Cytokines at Baseline | Postmenopausal Women | IL-8 | 3.19 | Standard Deviation 3.38 | pg/ug protein |
| Vaginal Cytokines at Baseline | Premenopausal Women | IL-1β | 0.12 | Standard Deviation 0.24 | pg/ug protein |
| Vaginal Cytokines at Baseline | Postmenopausal Women | IL-1β | 0.04 | Standard Deviation 0.04 | pg/ug protein |
| Vaginal Cytokines During Follow-up | Premenopausal Women | IL-8 at 14 days | 0.92 | Standard Deviation 1.40 | pg/ug protein |
| Vaginal Cytokines During Follow-up | Postmenopausal Women | IL-8 at 14 days | 1.34 | Standard Deviation 0.96 | pg/ug protein |
| Vaginal Cytokines During Follow-up | Premenopausal Women | IL-1B at 14 days | 0.02 | Standard Deviation 0.03 | pg/ug protein |
| Vaginal Cytokines During Follow-up | Postmenopausal Women | IL-1B at 14 days | 0.04 | Standard Deviation 0.07 | pg/ug protein |
| Vaginal Cytokines During Follow-up | Premenopausal Women | IL-8 at 28 days | 0.69 | Standard Deviation 0.33 | pg/ug protein |
| Vaginal Cytokines During Follow-up | Postmenopausal Women | IL-8 at 28 days | 1.69 | Standard Deviation 1.70 | pg/ug protein |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1.Premenopausal Women | 10 | |
| Overall Study | STARTED | 2.Postmenopausal Women With Hormones | 10 | |
| Overall Study | COMPLETED | 1.Premenopausal Women | 7 | |
| Overall Study | COMPLETED | 2.Postmenopausal Women With Hormones | 9 | |
| Overall Study | NOT COMPLETED | 1.Premenopausal Women | 3 | |
| Overall Study | NOT COMPLETED | 2.Postmenopausal Women With Hormones | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Premenopausal Women | 0 | 10 |
| Total, all-cause mortality | Postmenopausal Women | 0 | 10 |
| Total, other adverse events | Premenopausal Women | 0 | 10 |
| Total, other adverse events | Postmenopausal Women | 0 | 10 |
| Total, serious adverse events | Premenopausal Women | 0 | 10 |
| Total, serious adverse events | Postmenopausal Women | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Premenopausal Women vs Postmenopausal Women: deaths from any cause | Trial comparisons |
| Premenopausal Women vs Postmenopausal Women: 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/NCT02224313
GET https://conductscience.org/api/trials/v1/NCT02224313/registered