Table 4a.
Surrogates of contraceptive efficacy: Serum progesterone (P4) levels at intravaginal ring (IVR) removal, randomized by treatment group and visit, Kisumu, Kenya, 2019.
| P4 (ng/ml) | Treatment group | ||
|---|---|---|---|
| TFV/LNG IVR (n = 11) | TFV-only IVR (n = 11) | Placebo IVR (n = 5) | |
| Visit 6: day 20–25 of 1st menstrual cycle | |||
| Participants with P4 assessment | 11 | 11 | 5 |
| ≥3 | 4 (36.4%) | 9 (81.8%) | 5 (100.0%) |
| <3 | 7 (63.6%) | 2 (18.2%) | 0 (0.0%) |
| Visit 7: day 20–25 of 2nd menstrual cyclea | |||
| Participants with P4 assessment | 7 | 9 | 5 |
| ≥3 | 3 (42.9%) | 8 (88.9%) | 4 (80.0%) |
| <3 | 4 (57.1%) | 1 (11.1%) | 1 (20.0%) |
| Day 90 end of treatment (EOT) visit, pre-IVR removalb | |||
| Participants with P4 assessment | 3 | 6 | 2 |
| ≥3 | 1 (33.3%) | 3 (50.0%) | 2 (100.0%) |
| <3 | 2 (66.7%) | 3 (50.0%) | 0 (0.0%) |
P4, progesterone; IVR, intravaginal ring; TFV, tenofovir; LNG, levonorgestrel; EOT, end of treatment.
a
One participant is missing P4 at Visit 7; five participants discontinued IVR use prior to Visit 7.
b
One participant is missing P4 at Visit 9; 15 participants discontinued IVR use prior to 90 days.