Trial Outcomes & Findings for Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa (NCT NCT04669678)
NCT ID: NCT04669678
Last Updated: 2025-04-08
Results Overview
Mean hormone concentrations
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
at 2,4,8,12 weeks for IM DMPA and SC MPA or 2,4,8,12,20,24 weeks for ETG implants and IUD groups after contraceptive method initiation
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
Group 1 DOR + ETG
100mg DOR-containing ART \[oral tablet taken daily\] + 68mg ETG implant (follow up for 30 weeks)
Etonogestrel (ETG) implant: Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm. The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel). Implanon® consists of a single rod of ethylene vinyl acetate and contains 68 mg of ETG; it is manufactured by Merck and is approved for 3 years.
|
Group 2 DOR + IM DMPA
100mg DOR-containing ART \[oral tablet taken daily\] + 150mg IM DMPA (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
Group 3 DOR + SC MPA
100mg DOR-containing ART \[oral tablet taken daily\] + 104mg SC MPA (follow up for 18 weeks)
Sub-cutaneous medroxyprogesterone acetate (SC MPA): SC MPA or Sayana® Press is a single-dose container with 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL suspension for injection. Sayana® Press is indicated for medium-long term female contraception.
|
Group 4 DOR + IUD
100mg DOR-containing ART \[oral tablet taken daily\] + 1 non-hormonal IUD device (follow up for 30 weeks)
Non-hormonal intrauterine device (IUD): The NOVA T-380 non-hormonal IUD consists of a T-shaped polyethylene frame wound with copper wire, along with two monofilament threads to aid in removal of the IUD. IUDs may be left in place for up to 5 years.
|
Group 5 DTG + DMPA
50mg DTG-containing ART \[oral tablet taken daily\] + 150mg IM DMPA DMPA administered at enrolment (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
24
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
22
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa
Baseline characteristics by cohort
| Measure |
Group 1 DOR + ENG Implant
n=21 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 68mg ETG implant (follow up for 30 weeks)
Etonogestrel (ENG) implant: Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm. The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ENG, 3-keto desogestrel). Implanon® consists of a single rod of ethylene vinyl acetate and contains 68 mg of ENG; it is manufactured by Merck and is approved for 3 years.
|
Group 2 DOR + IM DMPA
n=21 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 150mg IM DMPA (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
Group 3 DOR + SC MPA
n=22 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 104mg SC MPA (follow up for 18 weeks)
Sub-cutaneous medroxyprogesterone acetate (SC MPA): SC MPA or Sayana® Press is a single-dose container with 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL suspension for injection. Sayana® Press is indicated for medium-long term female contraception.
|
Group 4 DOR + IUD
n=19 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 1 non-hormonal IUD device (follow up for 30 weeks)
Non-hormonal intrauterine device (IUD): The NOVA T-380 non-hormonal IUD consists of a T-shaped polyethylene frame wound with copper wire, along with two monofilament threads to aid in removal of the IUD. IUDs may be left in place for up to 5 years.
|
Group 5 DTG + DMPA
n=21 Participants
50mg DTG-containing ART \[oral tablet taken daily\] + 150mg IM DMPA DMPA administered at enrolment (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
104 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
37 years
n=93 Participants
|
35 years
n=4 Participants
|
37 years
n=27 Participants
|
37 years
n=483 Participants
|
39 years
n=36 Participants
|
37 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
104 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black race
|
21 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
104 Participants
n=10 Participants
|
|
Region of Enrollment
South Africa
|
21 participants
n=93 Participants
|
21 participants
n=4 Participants
|
22 participants
n=27 Participants
|
19 participants
n=483 Participants
|
21 participants
n=36 Participants
|
104 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: at 2,4,8,12 weeks for IM DMPA and SC MPA or 2,4,8,12,20,24 weeks for ETG implants and IUD groups after contraceptive method initiationPopulation: Data was collected at 2,4,8,12, 20 and 24 weeks for Group 1 DOR + ETG; at 2,4,8, and 12 weeks for Group 2 DOR + IM DMPA; at 2,4,8, and 12 weeks for Group 3 DOR SC MPA ; at 2,4,8 and 12 weeks for Group 5 DTG+DMPA. The Group 4 DOR+IUD group was not analyzed for hormonal concentrations as the group involves non-hormonal contraception, as per planned statistical analyses.
Mean hormone concentrations
Outcome measures
| Measure |
Group 1 DOR + ETG
n=21 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 68mg ETG implant (follow up for 30 weeks)
Etonogestrel (ETG) implant: Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm. The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel). Implanon® consists of a single rod of ethylene vinyl acetate and contains 68 mg of ETG; it is manufactured by Merck and is approved for 3 years.
|
Group 2 DOR + IM DMPA
n=21 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 150mg IM DMPA (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
Group 3 DOR + SC MPA
n=22 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 104mg SC MPA (follow up for 18 weeks)
Sub-cutaneous medroxyprogesterone acetate (SC MPA): SC MPA or Sayana® Press is a single-dose container with 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL suspension for injection. Sayana® Press is indicated for medium-long term female contraception.
|
Group 4 DOR + IUD
100mg DOR-containing ART \[oral tablet taken daily\] + 1 non-hormonal IUD device (follow up for 30 weeks)
Non-hormonal intrauterine device (IUD): The NOVA T-380 non-hormonal IUD consists of a T-shaped polyethylene frame wound with copper wire, along with two monofilament threads to aid in removal of the IUD. IUDs may be left in place for up to 5 years.
|
Group 5 DTG + DMPA
n=21 Participants
50mg DTG-containing ART \[oral tablet taken daily\] + 150mg IM DMPA DMPA administered at enrolment (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
|---|---|---|---|---|---|
|
Hormonal Contraceptive Concentrations
Week 8
|
519 pg/mL
Interval 163.0 to 2827.0
|
805 pg/mL
Interval 222.0 to 2310.0
|
321 pg/mL
Interval 101.0 to 658.0
|
—
|
984 pg/mL
Interval 148.0 to 2136.0
|
|
Hormonal Contraceptive Concentrations
Week 12
|
475 pg/mL
Interval 85.0 to 953.0
|
535 pg/mL
Interval 295.0 to 1439.0
|
271 pg/mL
Interval 116.0 to 523.0
|
—
|
602 pg/mL
Interval 13.0 to 3569.0
|
|
Hormonal Contraceptive Concentrations
Week 2
|
589 pg/mL
Interval 193.0 to 954.0
|
1293 pg/mL
Interval 2.0 to 2852.0
|
542 pg/mL
Interval 198.0 to 1067.0
|
—
|
1761 pg/mL
Interval 577.0 to 3610.0
|
|
Hormonal Contraceptive Concentrations
Week 4
|
550 pg/mL
Interval 157.0 to 4014.0
|
1047 pg/mL
Interval 514.0 to 3913.0
|
412 pg/mL
Interval 156.0 to 1091.0
|
—
|
1283 pg/mL
Interval 384.0 to 4098.0
|
|
Hormonal Contraceptive Concentrations
Week 20
|
390 pg/mL
Interval 196.0 to 819.0
|
—
|
—
|
—
|
—
|
|
Hormonal Contraceptive Concentrations
Week 24
|
378 pg/mL
Interval 111.0 to 521.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: at 2,4,8,12 weeks for IM and SC DMPA or 2,4,8,12,20,24 weeks for ETG implants and IUD groups after contraceptive method initiationPopulation: Data was collected at 2,4,8,12, 20 and 24 weeks for Group 1 DOR + ETG; at 2,4,8, and 12 weeks for Group 2 DOR + IM DMPA; at 2,4,8, and 12 weeks for Group 3 DOR + SC MPA ; at 2,4,8 and 12 weeks for Group 4 DOR + IUD. The Group 5 DTG + DMPA group was not analyzed for doravirine(DOR) concentrations as the group involves DTG instead of DOR, as per planned statistical analyses.
Mean DOR concentration at 24 hours (C24 hours)
Outcome measures
| Measure |
Group 1 DOR + ETG
n=21 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 68mg ETG implant (follow up for 30 weeks)
Etonogestrel (ETG) implant: Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm. The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel). Implanon® consists of a single rod of ethylene vinyl acetate and contains 68 mg of ETG; it is manufactured by Merck and is approved for 3 years.
|
Group 2 DOR + IM DMPA
n=21 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 150mg IM DMPA (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
Group 3 DOR + SC MPA
n=22 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 104mg SC MPA (follow up for 18 weeks)
Sub-cutaneous medroxyprogesterone acetate (SC MPA): SC MPA or Sayana® Press is a single-dose container with 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL suspension for injection. Sayana® Press is indicated for medium-long term female contraception.
|
Group 4 DOR + IUD
n=19 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 1 non-hormonal IUD device (follow up for 30 weeks)
Non-hormonal intrauterine device (IUD): The NOVA T-380 non-hormonal IUD consists of a T-shaped polyethylene frame wound with copper wire, along with two monofilament threads to aid in removal of the IUD. IUDs may be left in place for up to 5 years.
|
Group 5 DTG + DMPA
50mg DTG-containing ART \[oral tablet taken daily\] + 150mg IM DMPA DMPA administered at enrolment (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
|---|---|---|---|---|---|
|
DOR Concentrations
Week 2
|
706 ng/mL
Interval 26.0 to 2852.0
|
609 ng/mL
Interval 30.0 to 1752.0
|
836 ng/mL
Interval 62.0 to 1653.0
|
414 ng/mL
Interval 24.0 to 1472.0
|
—
|
|
DOR Concentrations
Week 4
|
897 ng/mL
Interval 268.0 to 1773.0
|
906 ng/mL
Interval 101.0 to 1500.0
|
770 ng/mL
Interval 368.0 to 2142.0
|
785 ng/mL
Interval 34.0 to 1381.0
|
—
|
|
DOR Concentrations
Week 8
|
916 ng/mL
Interval 36.0 to 2769.0
|
778 ng/mL
Interval 213.0 to 1167.0
|
1002 ng/mL
Interval 58.0 to 1833.0
|
894 ng/mL
Interval 61.0 to 1168.0
|
—
|
|
DOR Concentrations
Week 12
|
976 ng/mL
Interval 546.0 to 2853.0
|
1068 ng/mL
Interval 476.0 to 1513.0
|
1141 ng/mL
Interval 509.0 to 2712.0
|
650 ng/mL
Interval 49.0 to 984.0
|
—
|
|
DOR Concentrations
Week 20
|
919 ng/mL
Interval 83.5 to 1522.0
|
—
|
—
|
948 ng/mL
Interval 183.0 to 1756.0
|
—
|
|
DOR Concentrations
Week 24
|
1147 ng/mL
Interval 188.0 to 1916.0
|
—
|
—
|
766 ng/mL
Interval 262.0 to 1006.0
|
—
|
SECONDARY outcome
Timeframe: at 12-24 weeks after contraceptive initiationDOR-containing ART efficacy via HIV viral load \<40 copies/mL
Outcome measures
| Measure |
Group 1 DOR + ETG
n=21 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 68mg ETG implant (follow up for 30 weeks)
Etonogestrel (ETG) implant: Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm. The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel). Implanon® consists of a single rod of ethylene vinyl acetate and contains 68 mg of ETG; it is manufactured by Merck and is approved for 3 years.
|
Group 2 DOR + IM DMPA
n=21 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 150mg IM DMPA (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
Group 3 DOR + SC MPA
n=22 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 104mg SC MPA (follow up for 18 weeks)
Sub-cutaneous medroxyprogesterone acetate (SC MPA): SC MPA or Sayana® Press is a single-dose container with 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL suspension for injection. Sayana® Press is indicated for medium-long term female contraception.
|
Group 4 DOR + IUD
n=19 Participants
100mg DOR-containing ART \[oral tablet taken daily\] + 1 non-hormonal IUD device (follow up for 30 weeks)
Non-hormonal intrauterine device (IUD): The NOVA T-380 non-hormonal IUD consists of a T-shaped polyethylene frame wound with copper wire, along with two monofilament threads to aid in removal of the IUD. IUDs may be left in place for up to 5 years.
|
Group 5 DTG + DMPA
n=21 Participants
50mg DTG-containing ART \[oral tablet taken daily\] + 150mg IM DMPA DMPA administered at enrolment (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
|---|---|---|---|---|---|
|
Number of Participants With HIV Viral Suppression (i.e. ART Efficacy)
|
18 Participants
|
18 Participants
|
18 Participants
|
16 Participants
|
18 Participants
|
Adverse Events
Group 1 DOR + ETG
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Group 2 DOR + IM DMPA
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Group 3 DOR + SC MPA
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Group 4 DOR + IUD
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 5 DTG + DMPA
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 DOR + ETG
n=21 participants at risk
100mg DOR-containing ART \[oral tablet taken daily\] + 68mg ETG implant (follow up for 30 weeks)
Etonogestrel (ETG) implant: Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm. The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel). Implanon® consists of a single rod of ethylene vinyl acetate and contains 68 mg of ETG; it is manufactured by Merck and is approved for 3 years.
|
Group 2 DOR + IM DMPA
n=21 participants at risk
100mg DOR-containing ART \[oral tablet taken daily\] + 150mg IM DMPA (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
Group 3 DOR + SC MPA
n=22 participants at risk
100mg DOR-containing ART \[oral tablet taken daily\] + 104mg SC MPA (follow up for 18 weeks)
Sub-cutaneous medroxyprogesterone acetate (SC MPA): SC MPA or Sayana® Press is a single-dose container with 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL suspension for injection. Sayana® Press is indicated for medium-long term female contraception.
|
Group 4 DOR + IUD
n=19 participants at risk
100mg DOR-containing ART \[oral tablet taken daily\] + 1 non-hormonal IUD device (follow up for 30 weeks)
Non-hormonal intrauterine device (IUD): The NOVA T-380 non-hormonal IUD consists of a T-shaped polyethylene frame wound with copper wire, along with two monofilament threads to aid in removal of the IUD. IUDs may be left in place for up to 5 years.
|
Group 5 DTG + DMPA
n=21 participants at risk
50mg DTG-containing ART \[oral tablet taken daily\] + 150mg IM DMPA DMPA administered at enrolment (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
5.3%
1/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
4.5%
1/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
Other adverse events
| Measure |
Group 1 DOR + ETG
n=21 participants at risk
100mg DOR-containing ART \[oral tablet taken daily\] + 68mg ETG implant (follow up for 30 weeks)
Etonogestrel (ETG) implant: Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm. The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel). Implanon® consists of a single rod of ethylene vinyl acetate and contains 68 mg of ETG; it is manufactured by Merck and is approved for 3 years.
|
Group 2 DOR + IM DMPA
n=21 participants at risk
100mg DOR-containing ART \[oral tablet taken daily\] + 150mg IM DMPA (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
Group 3 DOR + SC MPA
n=22 participants at risk
100mg DOR-containing ART \[oral tablet taken daily\] + 104mg SC MPA (follow up for 18 weeks)
Sub-cutaneous medroxyprogesterone acetate (SC MPA): SC MPA or Sayana® Press is a single-dose container with 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL suspension for injection. Sayana® Press is indicated for medium-long term female contraception.
|
Group 4 DOR + IUD
n=19 participants at risk
100mg DOR-containing ART \[oral tablet taken daily\] + 1 non-hormonal IUD device (follow up for 30 weeks)
Non-hormonal intrauterine device (IUD): The NOVA T-380 non-hormonal IUD consists of a T-shaped polyethylene frame wound with copper wire, along with two monofilament threads to aid in removal of the IUD. IUDs may be left in place for up to 5 years.
|
Group 5 DTG + DMPA
n=21 participants at risk
50mg DTG-containing ART \[oral tablet taken daily\] + 150mg IM DMPA DMPA administered at enrolment (follow up for 18 weeks)
Intramuscular depo-medroxyprogesterone acetate (IM DMPA): DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
|
|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Gynaecological, etc.
|
38.1%
8/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
42.9%
9/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
50.0%
11/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
57.9%
11/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
38.1%
8/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Nervous system disorders
Neurological, eyes, etc.
|
52.4%
11/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
42.9%
9/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
50.0%
11/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
31.6%
6/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
33.3%
7/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Gastrointestinal disorders
Gastrointestinal, etc.
|
33.3%
7/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
42.9%
9/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
36.4%
8/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
26.3%
5/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
14.3%
3/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Skin and subcutaneous tissue disorders
Skin, alopecia, etc.
|
28.6%
6/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
23.8%
5/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
27.3%
6/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
5.3%
1/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
14.3%
3/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, etc.
|
28.6%
6/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
14.3%
3/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
31.8%
7/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
21.1%
4/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
19.0%
4/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, etc.
|
4.8%
1/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
4.8%
1/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
9.1%
2/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
26.3%
5/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
14.3%
3/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Ear and labyrinth disorders
Ear, nose and throat
|
9.5%
2/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
28.6%
6/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
4.5%
1/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
10.5%
2/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
9.5%
2/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
General disorders
Systemic, oral, oropharygyeal, etc.
|
19.0%
4/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
9.5%
2/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
9.1%
2/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
10.5%
2/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Cardiac disorders
Cardiovascular, etc.
|
4.8%
1/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
4.5%
1/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
10.5%
2/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
19.0%
4/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Blood and lymphatic system disorders
Dyslipidaemia, haematology, etc.
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
13.6%
3/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
5.3%
1/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Renal and urinary disorders
Urogenital, etc.
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
4.8%
1/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
5.3%
1/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
|
Injury, poisoning and procedural complications
Motor vehicle accident, etc.
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/22 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
5.3%
1/19 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
0.00%
0/21 • Adverse event data were collected per participant from study enrollment to study exit, the median number of days were 141 days (IQR is 131.8, 217) or approximately 4.7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60