Trial Outcomes & Findings for Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women (NCT NCT03282799)
NCT ID: NCT03282799
Last Updated: 2024-09-05
Results Overview
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.
COMPLETED
PHASE2
72 participants
3 months
2024-09-05
Participant Flow
Participant milestones
| Measure |
Standard Dose Etonogestrel Implant
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
34
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Standard Dose Etonogestrel Implant
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women
Baseline characteristics by cohort
| Measure |
Standard Dose Etonogestrel Implant
n=36 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
30 years
n=7 Participants
|
31 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ganda
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Nkore
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Nyarwanda
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Soga
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Tooro
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Kiga
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Uganda
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Weight
|
60.2 kg
n=5 Participants
|
59.2 kg
n=7 Participants
|
60.0 kg
n=5 Participants
|
|
CD4+ cell count
|
648 cells/mm3
n=5 Participants
|
700 cells/mm3
n=7 Participants
|
669 cells/mm3
n=5 Participants
|
|
Prior live births
|
3 births
n=5 Participants
|
3 births
n=7 Participants
|
3 births
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: One participant in the standard dose arm was withdrawn at week 1 of the study due to pregnancy.
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.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=35 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Proportion of Participants That Ovulate During Month 3
|
11 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: One participant in the standard dose arm was withdrawn at week 1 of the study due to pregnancy.
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.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=35 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Proportion of Participants That Ovulate During Month 6
|
17 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=34 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Proportion of Participants That Ovulate During Month 12
|
19 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=249 Cervical mucus samples
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=234 Cervical mucus samples
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Proportion of Cervical Mucus Scores Greater Than 10
Cervical mucus score greater than 10
|
1 Cervical mucus samples
|
1 Cervical mucus samples
|
|
Proportion of Cervical Mucus Scores Greater Than 10
Cervical mucus score of 10 or less
|
248 Cervical mucus samples
|
233 Cervical mucus samples
|
SECONDARY outcome
Timeframe: Day 0Population: Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week.
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.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=35 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Efavirenz Concentration at Enrollment
|
2.26 µg/mL
Interval 1.15 to 4.63
|
2.30 µg/mL
Interval 1.28 to 3.65
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 and 1 participant who missed the 4-week visit.
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.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=34 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Efavirenz Concentration at Week 4
|
2.41 µg/mL
Interval 1.47 to 4.26
|
2.23 µg/mL
Interval 1.38 to 5.46
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=34 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Efavirenz Concentration at Week 12
|
2.10 µg/mL
Interval 1.22 to 3.99
|
1.88 µg/mL
Interval 1.35 to 2.87
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week.
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.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=35 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Efavirenz Concentration at Week 24
|
2.26 µg/mL
Interval 1.31 to 4.12
|
1.76 µg/mL
Interval 1.18 to 3.47
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week.
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.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=35 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Efavirenz Concentration at Week 36
|
1.97 µg/mL
Interval 1.18 to 5.27
|
1.87 µg/mL
Interval 1.09 to 4.28
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=34 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Efavirenz Concentration at Week 48
|
2.05 µg/mL
Interval 1.36 to 3.66
|
1.72 µg/mL
Interval 1.01 to 2.73
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week.
Median etonogestrel concentrations measured in plasma samples collected 1 week after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=35 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Etonogestrel Concentration at Week 1
|
182 pg/mL
Interval 102.0 to 303.0
|
439 pg/mL
Interval 327.0 to 618.0
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week and 1 participant who missed the 4-week visit.
Median etonogestrel concentrations measured in plasma samples collected 4 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=34 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Etonogestrel Concentration at Week 4
|
115 pg/mL
Interval 79.0 to 178.0
|
282 pg/mL
Interval 158.0 to 414.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week and 1 participant who missed the 12-week visit.
Median etonogestrel concentrations measured in plasma samples collected 12 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=34 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Etonogestrel Concentration at Week 12
|
83 pg/mL
Interval 66.0 to 99.0
|
214 pg/mL
Interval 124.0 to 271.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week.
Median etonogestrel concentrations measured in plasma samples collected 24 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=35 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Etonogestrel Concentration at Week 24
|
69 pg/mL
Interval 41.0 to 99.0
|
168 pg/mL
Interval 91.0 to 224.0
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week.
Median etonogestrel concentrations measured in plasma samples collected 36 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=35 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Etonogestrel Concentration at Week 36
|
54 pg/mL
Interval 42.0 to 71.0
|
132 pg/mL
Interval 75.0 to 157.0
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week and 1 participant who missed the 48-week visit.
Median etonogestrel concentrations measured in plasma samples collected 48 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.
Outcome measures
| Measure |
Standard Dose Etonogestrel Implant
n=34 Participants
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 Participants
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Median Etonogestrel Concentration at Week 48
|
39 pg/mL
Interval 25.0 to 64.0
|
95 pg/mL
Interval 69.0 to 137.0
|
Adverse Events
Standard Dose Etonogestrel Implant
Increased Dose Etonogestrel Implant
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Dose Etonogestrel Implant
n=36 participants at risk
Single 68 mg etonogestrel implant
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
Increased Dose Etonogestrel Implant
n=36 participants at risk
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
|
|---|---|---|
|
Reproductive system and breast disorders
Amenorrhea
|
5.6%
2/36 • Number of events 2 • 48 weeks
|
8.3%
3/36 • Number of events 3 • 48 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
63.9%
23/36 • Number of events 40 • 48 weeks
|
83.3%
30/36 • Number of events 68 • 48 weeks
|
|
Reproductive system and breast disorders
Metrorrhagia
|
38.9%
14/36 • Number of events 20 • 48 weeks
|
61.1%
22/36 • Number of events 33 • 48 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
22.2%
8/36 • Number of events 10 • 48 weeks
|
27.8%
10/36 • Number of events 12 • 48 weeks
|
|
General disorders
Weight Gain
|
2.8%
1/36 • Number of events 1 • 48 weeks
|
8.3%
3/36 • Number of events 3 • 48 weeks
|
|
Nervous system disorders
Headache
|
44.4%
16/36 • Number of events 26 • 48 weeks
|
41.7%
15/36 • Number of events 23 • 48 weeks
|
|
Reproductive system and breast disorders
Breast Tenderness
|
2.8%
1/36 • Number of events 2 • 48 weeks
|
11.1%
4/36 • Number of events 5 • 48 weeks
|
|
Gastrointestinal disorders
Nausea
|
11.1%
4/36 • Number of events 5 • 48 weeks
|
11.1%
4/36 • Number of events 4 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
25.0%
9/36 • Number of events 9 • 48 weeks
|
16.7%
6/36 • Number of events 6 • 48 weeks
|
|
Product Issues
Implant Site Reaction
|
41.7%
15/36 • Number of events 19 • 48 weeks
|
66.7%
24/36 • Number of events 29 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place