Trial · NCT03343912
Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings
NCT03343912, Phase 1, Completed, Galeno Desenvolvimento de Pesquisas Clínicas
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings. Trials, record NCT03343912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03343912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings
- NCT number
- NCT03343912
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- Galeno Desenvolvimento de Pesquisas Clínicas
- Conditions
- Pregnancy
- Interventions
- Estriol 0.400 mg/day and Trimegestone 0.06 mg/day, Estriol 0.300 mg/day and Trimegestone 0.12 mg/day, Estriol 0.200 mg/day and Trimegestone 0.18 mg/day
- First posted
- 2017-11-17
- Last updated
- 2020-05-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of E2 and PG plasma levels | 0 - 41 days | Blood sampling for the determination of plasma levels of E2 and PG, in participants of each treatment group, as surrogate variables for treatment response. |
| Primary | Measurement of E3 and TMG plasma levels | 0 - 23 days | Blood sampling for the determination of plasma levels of E3 and TMG, in participants of each treatment group. |
| Secondary | Bleeding intensity | start of treatment until 42 days after treatment | Bleeding intensity, graded as "no bleeding", "spotting" or "bleeding" as recorded in diary by the subject on a daily basis |
| Secondary | Number of adverse events per participant | up to 42 days after treatment | Number of adverse events, in each treatment group, including clinically relevant alterations of vital signs and laboratory tests results |
| Secondary | Maximum Plasma Concentration (Cmax) of E3 and TMG | 0 - 23 days | Determination of Cmax for E3 and for TMG, based on plasma concentrations of samples obtained. |
| Secondary | Area Under the Curve (AUC) for E3 and TMG | 0 - 23 days | Calculation of the AUC for E3 and for TMG, based on plasma concentrations of samples obtained |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03343912
GET https://conductscience.org/api/trials/v1/NCT03343912/registered