Progesterone Augmentation of Nicotine Replacement Therapy Study
NCT02685072, Phase 4, Completed, Yale University; results first posted 2019-07-23
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Progesterone Augmentation of Nicotine Replacement Therapy Study | ClinicalTrials.gov |
| NCT number | NCT02685072 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 64 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Yale University | ClinicalTrials.gov |
| Conditions | Smoking Cessation | ClinicalTrials.gov |
| Interventions | Progesterone (200 mgs BID), Placebo | ClinicalTrials.gov |
| First posted | 2016-02-18 | ClinicalTrials.gov |
| Last updated | 2019-07-23 | ClinicalTrials.gov |
| Results first posted | 2019-07-23 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 7-day Point Prevalence of Smoking Abstinence | end of 8 weeks of treatment | The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days. | ClinicalTrials.gov |
| Secondary | Carbon Monoxide <10 Ppm | end of 8 weeks of treatment | Smoking abstinence measured by breath CO | ClinicalTrials.gov |
| Secondary | Carbon Monoxide <10 Ppm | 1 month follow up | Smoking abstinence measured by breath CO | ClinicalTrials.gov |
| Secondary | Carbon Monoxide <10 Ppm | 3 month follow up | Smoking abstinence measured by breath CO | ClinicalTrials.gov |
| Secondary | Change in Stroop Measure of Inhibitory Function | baseline and week 2 | The Stroop test assesses cognitive processing. The Level 3 Stroop Throughput score incorporates both accuracy and speed. In Level 3 of the Stroop test, a series of words representing colors are shown in a font color that is incongruent with the word (e.g. RED would be shown in blue font). Users are asked to press a response key associated with the color of the font, not the written word. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A Level 3 Stroop Throughput change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2. | ClinicalTrials.gov |
| Secondary | Change in Go/No Go Task Measure of Inhibitory Function | baseline and week 2 | Week 2 minus baseline. This task assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the "3". Go/No Go score is calculated as separation between the means of the signal and the noise distributions and is reported in standard deviation units, representing an overall indicator of performance since it accounts for correct responses and incorrect responses. Higher scores represent a better outcome. For the change score, higher positive scores represent greater improvement in scores between baseline and week 2, and lower negative scores represent greater decline in scores between baseline and week 2. | ClinicalTrials.gov |
| Secondary | Change in Digit Symbol Task Measure of Inhibitory Function | baseline and week 2 | The Code Substitution Test (a computerized adaptation/variant of the Digit Symbol Substitution Test) is a test of psychomotor performance. The Code Substitution-Learning Throughput Score incorporates both accuracy and speed. During the learning phase of this test, users are continuously shown a row of 9 digits that are paired with a symbol (the pairings are constant). Users are presented with a series of individual pairings and are asked to press a response key to indicate if the pairing is correct or not. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect Schedule (PANAS) Total Score | Baseline | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect Schedule (PANAS) Total Score | Week 2 | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect Schedule (PANAS) Total Score | Week 3 | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect Schedule (PANAS) Total Score | Week 4 | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect Schedule (PANAS) Total Score | Week 5 | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect Schedule (PANAS) Total Score | Week 6 | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect Schedule (PANAS) Total Score | Week 7 | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect Schedule (PANAS) Total Score | Week 8 | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect Schedule (PANAS) Total Score | 1 month follow up | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect Schedule (PANAS) Total Score | 3 month follow up | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Secondary | Prolonged Abstinence Post Trial | 1-month follow-up after end of treatment | Abstinence from 2 weeks post quit date to the one month follow up | ClinicalTrials.gov |
| Secondary | Prolonged Abstinence Follow up | 3-month follow-up after end of treatment | Abstinence from 2 weeks post quit date to 3 month follow up (total of 6-8 weeks during the trial and 3 month follow up) | ClinicalTrials.gov |
Outcomes 19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | 7-day Point Prevalence of Smoking Abstinence | end of 8 weeks of treatment | Participants (n=13 in TPN + Progesterone; n=9 in TPN + Placebo) missing outcome data were coded as not abstinent. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Carbon Monoxide <10 Ppm | end of 8 weeks of treatment | Participants (n=13 in TPN + Progesterone; n=10 in TPN + Placebo) missing breath CO were coded as ≥ 10 ppm (positive for smoking). | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Carbon Monoxide <10 Ppm | 1 month follow up | Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking). | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Carbon Monoxide <10 Ppm | 3 month follow up | Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking). | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Change in Stroop Measure of Inhibitory Function | baseline and week 2 | Includes people who completed Stroop Test at both baseline and Week 2 visits. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Go/No Go Task Measure of Inhibitory Function | baseline and week 2 | Includes participants who completed the Go/No Go task at both baseline and week 2 visits. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Digit Symbol Task Measure of Inhibitory Function | baseline and week 2 | Includes participants who completed the Code Substitution-Learning Test.at both baseline and week 2 visits. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Positive and Negative Affect Schedule (PANAS) Total Score | Baseline | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Positive and Negative Affect Schedule (PANAS) Total Score | Week 2 | Note: numbered analyzed does not equal 24 | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Positive and Negative Affect Schedule (PANAS) Total Score | Week 3 | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Positive and Negative Affect Schedule (PANAS) Total Score | Week 4 | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Positive and Negative Affect Schedule (PANAS) Total Score | Week 5 | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Positive and Negative Affect Schedule (PANAS) Total Score | Week 6 | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Positive and Negative Affect Schedule (PANAS) Total Score | Week 7 | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Positive and Negative Affect Schedule (PANAS) Total Score | Week 8 | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Positive and Negative Affect Schedule (PANAS) Total Score | 1 month follow up | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Positive and Negative Affect Schedule (PANAS) Total Score | 3 month follow up | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Prolonged Abstinence Post Trial | 1-month follow-up after end of treatment | Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking). | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Prolonged Abstinence Follow up | 3-month follow-up after end of treatment | Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking). | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
Results by group 70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| 7-day Point Prevalence of Smoking Abstinence | TNP + Progesterone | abstinent | 8 | Participants | ClinicalTrials.gov | |
| 7-day Point Prevalence of Smoking Abstinence | TNP + Placebo | abstinent | 11 | Participants | ClinicalTrials.gov | |
| 7-day Point Prevalence of Smoking Abstinence | TNP + Progesterone | not abstinent | 25 | Participants | ClinicalTrials.gov | |
| 7-day Point Prevalence of Smoking Abstinence | TNP + Placebo | not abstinent | 20 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Progesterone | CO <10 ppm | 9 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Placebo | CO <10 ppm | 8 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Progesterone | CO ≥ 10 ppm | 24 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Placebo | CO ≥ 10 ppm | 23 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Progesterone | CO <10 ppm | 6 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Placebo | CO <10 ppm | 7 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Progesterone | CO ≥ 10 ppm | 27 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Placebo | CO ≥ 10 ppm | 24 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Progesterone | CO <10 ppm | 10 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Placebo | CO <10 ppm | 10 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Progesterone | CO ≥ 10 ppm | 23 | Participants | ClinicalTrials.gov | |
| Carbon Monoxide <10 Ppm | TNP + Placebo | CO ≥ 10 ppm | 21 | Participants | ClinicalTrials.gov | |
| Change in Stroop Measure of Inhibitory Function | TNP + Progesterone | 4.1 | Standard Deviation 24.7 | units on a scale | ClinicalTrials.gov | |
| Change in Stroop Measure of Inhibitory Function | TNP + Placebo | -5.0 | Standard Deviation 28.7 | units on a scale | ClinicalTrials.gov | |
| Change in Go/No Go Task Measure of Inhibitory Function | TNP + Progesterone | 0.36 | Standard Deviation 2.33 | units on a scale | ClinicalTrials.gov | |
| Change in Go/No Go Task Measure of Inhibitory Function | TNP + Placebo | 0.50 | Standard Deviation 1.45 | units on a scale | ClinicalTrials.gov |
Participant flow 32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Treatment Period | STARTED | TNP + Progesterone | 33 | ClinicalTrials.gov | |
| Treatment Period | STARTED | TNP + Placebo | 31 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 2 Visit | TNP + Progesterone | 23 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 2 Visit | TNP + Placebo | 26 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 3 Visit | TNP + Progesterone | 20 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 3 Visit | TNP + Placebo | 23 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 4 Visit | TNP + Progesterone | 19 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 4 Visit | TNP + Placebo | 23 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 5 Visit | TNP + Progesterone | 19 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 5 Visit | TNP + Placebo | 22 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 6 Visit | TNP + Progesterone | 18 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 6 Visit | TNP + Placebo | 19 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 7 Visit | TNP + Progesterone | 17 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 7 Visit | TNP + Placebo | 18 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 8 Visit | TNP + Progesterone | 20 | ClinicalTrials.gov | |
| Treatment Period | Completed Week 8 Visit | TNP + Placebo | 22 | ClinicalTrials.gov | |
| Treatment Period | COMPLETED | TNP + Progesterone | 20 | ClinicalTrials.gov | |
| Treatment Period | COMPLETED | TNP + Placebo | 22 | ClinicalTrials.gov | |
| Treatment Period | NOT COMPLETED | TNP + Progesterone | 13 | ClinicalTrials.gov | |
| Treatment Period | NOT COMPLETED | TNP + Placebo | 9 | ClinicalTrials.gov |
Adverse events 14
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 | Source |
|---|---|---|---|---|---|---|---|
| other | nausea, vomiting, diarrhea | Gastrointestinal disorders | TNP + Progesterone | 1 | 33 | 1 | ClinicalTrials.gov |
| other | nausea, vomiting, diarrhea | Gastrointestinal disorders | TNP + Placebo | 0 | 31 | 0 | ClinicalTrials.gov |
| other | wrist and back injury due to fall | Musculoskeletal and connective tissue disorders | TNP + Progesterone | 1 | 33 | 1 | ClinicalTrials.gov |
| other | wrist and back injury due to fall | Musculoskeletal and connective tissue disorders | TNP + Placebo | 0 | 31 | 0 | ClinicalTrials.gov |
| other | Back pain | Musculoskeletal and connective tissue disorders | TNP + Progesterone | 1 | 33 | 1 | ClinicalTrials.gov |
| other | Back pain | Musculoskeletal and connective tissue disorders | TNP + Placebo | 0 | 31 | 0 | ClinicalTrials.gov |
| other | Muscle pain | Musculoskeletal and connective tissue disorders | TNP + Progesterone | 1 | 33 | 1 | ClinicalTrials.gov |
| other | Muscle pain | Musculoskeletal and connective tissue disorders | TNP + Placebo | 0 | 31 | 0 | ClinicalTrials.gov |
| other | ER visit for unknown reason | General disorders | TNP + Progesterone | 1 | 33 | 1 | ClinicalTrials.gov |
| other | ER visit for unknown reason | General disorders | TNP + Placebo | 2 | 31 | 2 | ClinicalTrials.gov |
| other | 3 Menses in one month | Reproductive system and breast disorders | TNP + Progesterone | 0 | 33 | 0 | ClinicalTrials.gov |
| other | 3 Menses in one month | Reproductive system and breast disorders | TNP + Placebo | 1 | 31 | 1 | ClinicalTrials.gov |
| other | Ovarian cyst | Reproductive system and breast disorders | TNP + Progesterone | 0 | 33 | 0 | ClinicalTrials.gov |
| other | Ovarian cyst | Reproductive system and breast disorders | TNP + Placebo | 2 | 31 | 2 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | TNP + Progesterone | 0 | 33 | ClinicalTrials.gov |
| Total, all-cause mortality | TNP + Placebo | 0 | 31 | ClinicalTrials.gov |
| Total, other adverse events | TNP + Progesterone | 4 | 33 | ClinicalTrials.gov |
| Total, other adverse events | TNP + Placebo | 4 | 31 | ClinicalTrials.gov |
| Total, serious adverse events | TNP + Progesterone | 0 | 33 | ClinicalTrials.gov |
| Total, serious adverse events | TNP + Placebo | 0 | 31 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R21CA198187 | Progesterone Augmentation for Smoking Cessation in Women | YONKERS, KIMBERLY A; SOFUOGLU, MEHMET | YALE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2015 to 2016 | NIH RePORTER |
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TNP + Progesterone vs TNP + Placebo: deaths from any cause | Trial comparisons |
| TNP + Progesterone vs TNP + Placebo: serious adverse events | Trial comparisons |
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)