Trial Outcomes & Findings for Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate (NCT NCT05294341)
NCT ID: NCT05294341
Last Updated: 2024-07-16
Results Overview
The change in serum concentration of norethindrone in individuals taking 0.35mg norethindrone and 5mg norethindrone acetate will be assessed daily over one week of medication use. Norethindrone levels are then averaged across all subjects teaching each medication in each sequence for days 1-7.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
Day 1-7
Results posted on
2024-07-16
Participant Flow
Participant milestones
| Measure |
5mg Norethindrone Acetate, Then 0.35mg Norethindrone
Participants first received 5mg norethindrone acetate first, then 0.35mg norethindrone. They self-administered 5mg norethindrone acetate between 6-8am on days 1-7 of the study. They then proceeded to get phlebotomy drawn one hour after taking 5mg norethindrone acetate. They then stopped taking 5mg norethindrone acetate day 8, and presented for hourly phlebotomy hourly, for 8 hours.
They they underwent a 1 month washout. Participants then received 0.35mg norethindrone. They self-administered 0.35mg norethindrone between 6-8am on days 1-7 of the study. They then proceeded to get phlebotomy drawn one hour after taking 0.35mg norethindrone. They then stopped taking 0.35mg norethindrone day 8, and presented for hourly phlebotomy hourly, for 8 hours.
|
0.35mg Norethindrone, Then 5mg Norethindrone Acetate
Participants first received 0.35mg norethindrone acetate first, then 5mg norethindrone acetate. They self-administered 0.35mg norethindrone between 6-8am on days 1-7 of the study. They then proceeded to get phlebotomy drawn one hour after taking 0.35mg norethindrone. They then stopped taking 0.35mg norethindrone day 8, and presented for hourly phlebotomy hourly, for 8 hours.
They they underwent a 1 month washout. Participants then received 5mg norethindrone acetate. They self-administered 5mg norethindrone acetate between 6-8am on days 1-7 of the study. They then proceeded to get phlebotomy drawn one hour after taking 5mg norethindrone acetate. They then stopped taking 5mg norethindrone acetate day 8, and presented for hourly phlebotomy hourly, for 8 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sequence 1
n=3 Participants
Sequence 1: 0.35mg norethindrone first, then 5mg norethindrone acetate
|
Sequence 2
n=3 Participants
Sequence 2: 5mg norethindrone acetate first, then 0.35mg norethindrone
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 2 • n=3 Participants
|
32 years
STANDARD_DEVIATION 2 • n=3 Participants
|
30 years
STANDARD_DEVIATION 4 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
|
Regular menstrual cycles, not on hormonal contraception
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day 1-7The change in serum concentration of norethindrone in individuals taking 0.35mg norethindrone and 5mg norethindrone acetate will be assessed daily over one week of medication use. Norethindrone levels are then averaged across all subjects teaching each medication in each sequence for days 1-7.
Outcome measures
| Measure |
5mg Norethindrone Acetate
n=6 Participants
These norethindrone levels were obtained via daily plasma samples on days 1-7 when subjects were assigned 5mg norethindrone acetate.
|
0.35mg Norethindrone
n=6 Participants
These norethindrone levels were obtained via daily plasma samples on days 1-7 when subjects were assigned 0.35mg norethindrone.
|
|---|---|---|
|
Serum Concentration of Norethindrone
Day 1
|
15.69 ng/ml
Standard Deviation 8.6
|
2.28 ng/ml
Standard Deviation 1.878562984
|
|
Serum Concentration of Norethindrone
Day 2
|
13.56 ng/ml
Standard Deviation 8.695089814
|
2.50 ng/ml
Standard Deviation 2.02
|
|
Serum Concentration of Norethindrone
Day 3
|
13.96 ng/ml
Standard Deviation 9.767023293
|
2.28 ng/ml
Standard Deviation 1.28
|
|
Serum Concentration of Norethindrone
Day 4
|
16.56 ng/ml
Standard Deviation 9.173183846
|
2.42 ng/ml
Standard Deviation 1.08
|
|
Serum Concentration of Norethindrone
Day 5
|
11.82 ng/ml
Standard Deviation 9.173183846
|
2.22 ng/ml
Standard Deviation 1.65
|
|
Serum Concentration of Norethindrone
Day 6
|
18.92 ng/ml
Standard Deviation 8.652213867
|
2.82 ng/ml
Standard Deviation 1.65
|
|
Serum Concentration of Norethindrone
Day 7
|
11.30 ng/ml
Standard Deviation 6.505930925
|
2.22 ng/ml
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Hourly for eight hours on Day 8The change in serum concentration of norethindrone in individuals taking 0.35mg norethindrone and 5mg norethindrone acetate will be assessed hourly for 8 hours in the absence of exposure to either medication. This is represented as a rate of decline.
Outcome measures
| Measure |
5mg Norethindrone Acetate
n=6 Participants
These norethindrone levels were obtained via daily plasma samples on days 1-7 when subjects were assigned 5mg norethindrone acetate.
|
0.35mg Norethindrone
n=6 Participants
These norethindrone levels were obtained via daily plasma samples on days 1-7 when subjects were assigned 0.35mg norethindrone.
|
|---|---|---|
|
Day 8 Norethindrone Levels
Hour 0
|
1.54 ng/mL
Standard Deviation 0.583608153
|
0.14729 ng/mL
Standard Deviation 0.07215209
|
|
Day 8 Norethindrone Levels
Hour 1
|
1.17 ng/mL
Standard Deviation 0.389190923
|
0.129893333 ng/mL
Standard Deviation 0.079030195
|
|
Day 8 Norethindrone Levels
Hour 2
|
1.31 ng/mL
Standard Deviation 0.451133779
|
0.149843333 ng/mL
Standard Deviation 0.071421545
|
|
Day 8 Norethindrone Levels
Hour 3
|
1.29 ng/mL
Standard Deviation 0.535815038
|
0.112873333 ng/mL
Standard Deviation 0.076
|
|
Day 8 Norethindrone Levels
Hour 4
|
1.13 ng/mL
Standard Deviation 0.480888744
|
0.11 ng/mL
Standard Deviation 0.084
|
|
Day 8 Norethindrone Levels
Hour 5
|
1.04 ng/mL
Standard Deviation 0.367513739
|
0.11041 ng/mL
Standard Deviation 0.11041
|
|
Day 8 Norethindrone Levels
Hour 6
|
0.99 ng/mL
Standard Deviation 0.38615963
|
0.096743333 ng/mL
Standard Deviation 0.067140596
|
|
Day 8 Norethindrone Levels
Hour 7
|
1.0 ng/mL
Standard Deviation 0.433300735
|
0.090736667 ng/mL
Standard Deviation 0.0645776
|
|
Day 8 Norethindrone Levels
Hour 8
|
1.03 ng/mL
Standard Deviation 0.463022482
|
0.089563333 ng/mL
Standard Deviation 0.063464118
|
SECONDARY outcome
Timeframe: Day 1 and Day 21The serum levels of estradiol, LH, FSH, and progesterone will be compared in individuals taking 0.35mg norethindrone and 5mg norethindrone acetate at study start and on Day 21
Outcome measures
| Measure |
5mg Norethindrone Acetate
n=6 Participants
These norethindrone levels were obtained via daily plasma samples on days 1-7 when subjects were assigned 5mg norethindrone acetate.
|
0.35mg Norethindrone
n=6 Participants
These norethindrone levels were obtained via daily plasma samples on days 1-7 when subjects were assigned 0.35mg norethindrone.
|
|---|---|---|
|
Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone
Estradiol Day 1
|
34.7 ng/mL
Standard Deviation 9.44
|
33.5 ng/mL
Standard Deviation 7.8
|
|
Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone
Estradiol Day 21
|
147 ng/mL
Standard Deviation 176
|
139 ng/mL
Standard Deviation 56.45
|
|
Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone
Progesterone Day 1
|
0.45 ng/mL
Standard Deviation 0.19
|
0.44 ng/mL
Standard Deviation 0.16
|
|
Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone
Progesterone Day 21
|
0.95 ng/mL
Standard Deviation 0.97
|
11.6 ng/mL
Standard Deviation 3.72
|
|
Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone
LH Day 1
|
6.73 ng/mL
Standard Deviation 1.56
|
7.4 ng/mL
Standard Deviation 1.4
|
|
Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone
LH Day 21
|
11.8 ng/mL
Standard Deviation 9.7
|
6.65 ng/mL
Standard Deviation 5.37
|
|
Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone
FSH Day 1
|
8.73 ng/mL
Standard Deviation 3.5
|
8.53 ng/mL
Standard Deviation 3.2
|
|
Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone
FSH Day 21
|
6.7 ng/mL
Standard Deviation 3.1
|
2.75 ng/mL
Standard Deviation 0.3
|
Adverse Events
5mg Norethindrone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.35mg Norethindrone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Halina Yee; Primary Resident Investigator
Hershey Medical Center
Phone: 7175313503
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place