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Table 1 Patient Demographics and summary of results of randomized trial

From: Norethindrone is superior to combined oral contraceptive pills in short-term delay of menses and onset of breakthrough bleeding: a randomized trial

Estimated Norethindrone Control Group (OCP) p
N 23 23  
Age 27.7 (18–33) (0.883) 28.0 (18–33) (.916) 0.865
Race White (26%), Hispanic (26%) White (30%), Hispanic (18%) ns
African-American (22%), African-American (30%),
Asian (9%), Indian (13%) Asian (13%), Indian (9%)
Other (4%)  
Nulligravid 11 12 0.768
Weight 147.1 (96–221) (6.733) 149.3 (100–235) (7.75) 0.987
Cycle day start 8.8 (2–14a) (0.613) 8.2 (3–12) (0.603) 0.514
Time to event 29.7 (21–42) (1.405) 30.61 (22–40) (1.283) 0.650
Days on therapy 33.4 (28–45) (1.152) 33.2 (23–43) (1.177) 0.916
Patients missing > 2 doses 0 1 0.312
Patients with breakthrough bleed 2a 10 0.007
Average day bleed occurred 16.5 (14–19) 15.25 (10–23) (1.47) NA
Amount breakthrough bleeding 1 1.5 (1–3) (0.726) 0.321
Mean weight gain on therapy Of those, > 5 lbs. persistence at 1wk 3.6 (0–7) (0.469) 2.2 (0–6) (0.435) 0.023
0 0
Patients with side effects 5 12 0.054
Side effects bloating (3), spotting (2) bloating (2), spotting (9)  
weight gain (4), nausea (1) heavier bleeding (1), nausea (3)
headache (1) headache (2), sore breasts (2)
Days stop therapy to menses 3 (2–4) (0.167) 3.17 (2–4) (0.136) 0.537
Patients reporting light/normal flow 13 20 0.047
Reported duration of flow as normal or shorter 15 14 0.395
Satisfaction Score 4.09 (3–5) (0.153) 3.56 (2–5) (0.176) 0.041
Likely to use method again 4.13 (3–5) (0.158) 3.522 (2–5) (0.165) 0.013
Likely to recommend method 4.17 (3–5) (0.162) 3.39 (2–5) (0.137) 0.002
Unintended pregnancies 0 0  
Desire to conceive in 1 year 4 5 0.710
Time to conceive (months) 2.0 (1–3) (0.170) 3.6 (3–5) (0.186) 0.032
  1. (aOne patient in the treatment group was mistakenly enrolled at cycle day 14 and has been included in the analysis). Mean, range and standard error of the mean are shown
  2. The bold on the rightmost column is for p <0.05 as significant