Trial Outcomes & Findings for Use of Norethindrone Acetate for Management of Bleeding Associated With the Etonogestrel Contraceptive Implant (NCT NCT02353247)

Last Updated: 2022-03-16

Results Overview

"Bothersome bleeding" was defined per WHO classification as either frequent bleeding (greater than 5 bleeding-spotting episodes in a 90-day reference period) or prolonged bleeding (any bleeding-spotting episode, uninterrupted, lasting greater than 14 days in a 90-day reference period) The scale used was derived from the WHO classification system: Bleeding Day (assigned value = 1) Spotting Day (assigned value = .5) Bleeding Free Day (assigned value = 0) Prefer not to answer today (assigned value = missing) Higher scores (average of the time period) indicate more bothersome bleeding; low scores indicate less bothersome bleeding. Less bothersome bleeding is the desired outcome. Note, the scale is not a published scale but rather was constructed for this study.

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

Initial 3 months of baseline collection (medicine free); For intervention group, 3 months of medicine, followed by 3 months of medicine free; For control group, 6 months of medicine free.

Results posted on

2022-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Study Arm Intervention Group	Control Group No intervention	Consented, Never Randomized For various reasons (e.g., lost phone access), never responded to initial text survey. As a result, they were not randomized to groups nor tracked during study. Baseline data was collected immediately after consenting.
Overall Study STARTED	30	23	35
Overall Study COMPLETED	21	18	0
Overall Study NOT COMPLETED	9	5	35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Norethindrone Acetate for Management of Bleeding Associated With the Etonogestrel Contraceptive Implant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Intervention (Completed) n=18 Participants Completed the full study (at least 70%)	No Intervention (Did Not Complete) n=5 Participants Took med off protocol Responded to less than 70% of text messages	Intervention (Complete) n=21 Participants Completed the full study (at least 70%)	Intervention (Did Not Complete) n=9 Participants Non compliant with medication Requested medication off protocol	Consented, Never Assigned to Group n=35 Participants Reasons include: Minimal response, no show to visit Never responded, no show to visit Technical difficulties Desired to be off all medications Loss of phone privileges Never Got Texts Cell# Changed Too Busy Unknown	Total n=88 Participants Total of all reporting groups
Age, Continuous	15.78 years STANDARD_DEVIATION 2.13 • n=5 Participants	17.33 years STANDARD_DEVIATION .57 • n=7 Participants	15.24 years STANDARD_DEVIATION 1.55 • n=5 Participants	16.17 years STANDARD_DEVIATION .98 • n=4 Participants	16.25 years STANDARD_DEVIATION 2.02 • n=21 Participants	15.93 years STANDARD_DEVIATION 1.88 • n=8 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	5 Participants n=7 Participants	21 Participants n=5 Participants	9 Participants n=4 Participants	35 Participants n=21 Participants	88 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	15 Participants n=21 Participants	33 Participants n=8 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	0 Participants n=7 Participants	16 Participants n=5 Participants	4 Participants n=4 Participants	18 Participants n=21 Participants	53 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
BMI	25.63 kg/m^2 STANDARD_DEVIATION 6.32 • n=5 Participants	27.19 kg/m^2 STANDARD_DEVIATION 8.26 • n=7 Participants	26.97 kg/m^2 STANDARD_DEVIATION 7.18 • n=5 Participants	27.62 kg/m^2 STANDARD_DEVIATION 5.57 • n=4 Participants	26.41 kg/m^2 STANDARD_DEVIATION 5.81 • n=21 Participants	26.50 kg/m^2 STANDARD_DEVIATION 6.22 • n=8 Participants
Insurance Private	7 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	12 Participants n=21 Participants	29 Participants n=8 Participants
Insurance Public	11 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants	5 Participants n=4 Participants	23 Participants n=21 Participants	53 Participants n=8 Participants
Insurance Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants
# Lifetime Sexual Partners	.93 Partners STANDARD_DEVIATION 1.1 • n=5 Participants	3.33 Partners STANDARD_DEVIATION 4.04 • n=7 Participants	.59 Partners STANDARD_DEVIATION .62 • n=5 Participants	3.83 Partners STANDARD_DEVIATION 4.62 • n=4 Participants	1.69 Partners STANDARD_DEVIATION 1.53 • n=21 Participants	1.52 Partners STANDARD_DEVIATION 2.03 • n=8 Participants
Age of Menarche	12 years STANDARD_DEVIATION 1.14 • n=5 Participants	12 years STANDARD_DEVIATION 1.00 • n=7 Participants	11.52 years STANDARD_DEVIATION 1.21 • n=5 Participants	12.67 years STANDARD_DEVIATION 1.21 • n=4 Participants	11.25 years STANDARD_DEVIATION 1.92 • n=21 Participants	11.61 years STANDARD_DEVIATION 1.57 • n=8 Participants

PRIMARY outcome

Timeframe: Initial 3 months of baseline collection (medicine free); For intervention group, 3 months of medicine, followed by 3 months of medicine free; For control group, 6 months of medicine free.