Trial · NCT03282799
Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women
NCT03282799, Phase 2, Completed, Catherine Anne Chappell; results first posted 2024-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women. Trials, record NCT03282799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03282799
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women
- NCT number
- NCT03282799
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- Catherine Anne Chappell
- Conditions
- HIV/AIDS, Contraception
- Interventions
- etonogestrel implant
- First posted
- 2017-09-14
- Last updated
- 2024-09-05
- Results first posted
- 2024-09-05
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants That Ovulate During Month 3 | 3 months | Proportion of participants that experience at least one ovulation during month 3 of etonogestrel implant use. Serum progesterone concentrations are measured weekly during month 3 (weeks 9-12). Ovulation is defined as endogenous progesterone concentrations of \>3 ng/mL. |
| Primary | Proportion of Participants That Ovulate During Month 6 | 6 months | Proportion of participants that experience at least one ovulation during month 6 of etonogestrel implant use. Serum progesterone concentrations are measured weekly during month 6 (weeks 21-24). Ovulation is defined as endogenous progesterone concentrations of \>3 ng/mL. |
| Primary | Proportion of Participants That Ovulate During Month 12 | 12 months | Proportion of participants that experience at least one ovulation during month 12 of etonogestrel implant use. Serum progesterone concentrations are measured weekly during month 12 (weeks 45-48). Ovulation is defined as endogenous progesterone concentrations of \>3 ng/mL. |
| Secondary | Proportion of Cervical Mucus Scores Greater Than 10 | 12 months | The proportion of World Health Organization cervical mucus scores that are greater than 10 from weekly samples collected during months 3, 6 and 12 of etonogestrel implant use. A cervical mucus score greater than 10 indicates the mucus is favorable for sperm penetration or lack of contraceptive effect. The cervical mucus score ranges from 0 indicating least favorable for sperm penetration to 15 for most favorable for sperm penetration. |
| Secondary | Median Efavirenz Concentration at Enrollment | Day 0 | Median efavirenz concentrations measured in plasma samples collected at enrollment, prior to insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection. |
| Secondary | Median Efavirenz Concentration at Week 4 | 4 weeks | Median efavirenz concentrations measured in plasma samples collected 4 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection. |
| Secondary | Median Efavirenz Concentration at Week 12 | 12 weeks | Median efavirenz concentrations measured in plasma samples collected 12 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection. |
| Secondary | Median Efavirenz Concentration at Week 24 | 24 weeks | Median efavirenz concentrations measured in plasma samples collected 24 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection. |
| Secondary | Median Efavirenz Concentration at Week 36 | 36 weeks | Median efavirenz concentrations measured in plasma samples collected 36 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection. |
| Secondary | Median Efavirenz Concentration at Week 48 | 48 weeks | Median efavirenz concentrations measured in plasma samples collected 48 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants That Ovulate During Month 3 | 3 months | One participant in the standard dose arm was withdrawn at week 1 of the study due to pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Proportion of Participants That Ovulate During Month 6 | 6 months | One participant in the standard dose arm was withdrawn at week 1 of the study due to pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Proportion of Participants That Ovulate During Month 12 | 12 months | One participant in the standard dose arm was withdrawn at week 1 of the study due to pregnancy, and one was withdrawn at week 45 due to a mental health condition. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Cervical Mucus Scores Greater Than 10 | 12 months | Evaluable cervical mucus samples collected from participants over 48 weeks of etonogestrel implant use. One participant in the standard dose arm was withdrawn at week 1 of the study due to pregnancy. | Cervical mucus samples | COUNT_OF_UNITS |
| SECONDARY | Median Efavirenz Concentration at Enrollment | Day 0 | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week. | µg/mL | MEDIAN |
| SECONDARY | Median Efavirenz Concentration at Week 4 | 4 weeks | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 and 1 participant who missed the 4-week visit. | µg/mL | MEDIAN |
| SECONDARY | Median Efavirenz Concentration at Week 12 | 12 weeks | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week and 1 participant who missed the 12-week visit. | µg/mL | MEDIAN |
| SECONDARY | Median Efavirenz Concentration at Week 24 | 24 weeks | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week. | µg/mL | MEDIAN |
| SECONDARY | Median Efavirenz Concentration at Week 36 | 36 weeks | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week. | µg/mL | MEDIAN |
| SECONDARY | Median Efavirenz Concentration at Week 48 | 48 weeks | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week and 1 participant who missed the 48-week visit. | µg/mL | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants That Ovulate During Month 3 | Standard Dose Etonogestrel Implant | 11 | Participants | ||
| Proportion of Participants That Ovulate During Month 3 | Increased Dose Etonogestrel Implant | 0 | Participants | ||
| Proportion of Participants That Ovulate During Month 6 | Standard Dose Etonogestrel Implant | 17 | Participants | ||
| Proportion of Participants That Ovulate During Month 6 | Increased Dose Etonogestrel Implant | 0 | Participants | ||
| Proportion of Participants That Ovulate During Month 12 | Standard Dose Etonogestrel Implant | 19 | Participants | ||
| Proportion of Participants That Ovulate During Month 12 | Increased Dose Etonogestrel Implant | 2 | Participants | ||
| Proportion of Cervical Mucus Scores Greater Than 10 | Standard Dose Etonogestrel Implant | Cervical mucus score greater than 10 | 1 | Cervical mucus samples | |
| Proportion of Cervical Mucus Scores Greater Than 10 | Increased Dose Etonogestrel Implant | Cervical mucus score greater than 10 | 1 | Cervical mucus samples | |
| Proportion of Cervical Mucus Scores Greater Than 10 | Standard Dose Etonogestrel Implant | Cervical mucus score of 10 or less | 248 | Cervical mucus samples | |
| Proportion of Cervical Mucus Scores Greater Than 10 | Increased Dose Etonogestrel Implant | Cervical mucus score of 10 or less | 233 | Cervical mucus samples |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Dose Etonogestrel Implant | 36 | |
| Overall Study | STARTED | Increased Dose Etonogestrel Implant | 36 | |
| Overall Study | COMPLETED | Standard Dose Etonogestrel Implant | 34 | |
| Overall Study | COMPLETED | Increased Dose Etonogestrel Implant | 36 | |
| Overall Study | NOT COMPLETED | Standard Dose Etonogestrel Implant | 2 | |
| Overall Study | NOT COMPLETED | Increased Dose Etonogestrel Implant | 0 |
Source ClinicalTrials.gov
Adverse events20
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 | Amenorrhea | Reproductive system and breast disorders | Standard Dose Etonogestrel Implant | 2 | 36 | 2 |
| other | Amenorrhea | Reproductive system and breast disorders | Increased Dose Etonogestrel Implant | 3 | 36 | 3 |
| other | Menorrhagia | Reproductive system and breast disorders | Standard Dose Etonogestrel Implant | 23 | 36 | 40 |
| other | Menorrhagia | Reproductive system and breast disorders | Increased Dose Etonogestrel Implant | 30 | 36 | 68 |
| other | Metrorrhagia | Reproductive system and breast disorders | Standard Dose Etonogestrel Implant | 14 | 36 | 20 |
| other | Metrorrhagia | Reproductive system and breast disorders | Increased Dose Etonogestrel Implant | 22 | 36 | 33 |
| other | Dysmenorrhea | Reproductive system and breast disorders | Standard Dose Etonogestrel Implant | 8 | 36 | 10 |
| other | Dysmenorrhea | Reproductive system and breast disorders | Increased Dose Etonogestrel Implant | 10 | 36 | 12 |
| other | Weight Gain | General disorders | Standard Dose Etonogestrel Implant | 1 | 36 | 1 |
| other | Weight Gain | General disorders | Increased Dose Etonogestrel Implant | 3 | 36 | 3 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Dose Etonogestrel Implant | 0 | 36 |
| Total, all-cause mortality | Increased Dose Etonogestrel Implant | 0 | 36 |
| Total, other adverse events | Standard Dose Etonogestrel Implant | 35 | 36 |
| Total, other adverse events | Increased Dose Etonogestrel Implant | 35 | 36 |
| Total, serious adverse events | Standard Dose Etonogestrel Implant | 0 | 36 |
| Total, serious adverse events | Increased Dose Etonogestrel Implant | 0 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38458408 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant: Proportion of Participants That Ovulate During Month 12 | Trial comparisons |
| Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant: Proportion of Participants That Ovulate During Month 6 | Trial comparisons |
| Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant: Proportion of Participants That Ovulate During Month 3 | Trial comparisons |
| Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant: deaths from any cause | Trial comparisons |
| Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant: 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/NCT03282799
GET https://conductscience.org/api/trials/v1/NCT03282799/results?page=2