Skip to main content

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