Trial Outcomes & Findings for Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers (NCT NCT04964193)
NCT ID: NCT04964193
Last Updated: 2022-01-31
Results Overview
Maximum plasma concentration (Cmax)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
before dosing (0 h) and at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
Results posted on
2022-01-31
Participant Flow
Participant milestones
| Measure |
Test Drug First, Then Reference Drug
New (test) Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the first intervention period, and marketed (reference) Diane®-35 sugar-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the second intervention period (after washout period).
|
Diane-35 Sugar-coated Tablet
Marketed (reference) Diane-35 Sugar-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the first intervention period, and new (test) Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the second intervention period (after washout period).
|
|---|---|---|
|
1st Intervention
STARTED
|
12
|
12
|
|
1st Intervention
COMPLETED
|
12
|
12
|
|
1st Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout = Three Weeks
STARTED
|
12
|
12
|
|
Washout = Three Weeks
COMPLETED
|
12
|
12
|
|
Washout = Three Weeks
NOT COMPLETED
|
0
|
0
|
|
2nd Intervention
STARTED
|
12
|
12
|
|
2nd Intervention
COMPLETED
|
12
|
12
|
|
2nd Intervention
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 |
Total Number of Participants
n=24 Participants
All participants received 2 mg cyproterone acetate + 0.035 mg ethinylestradiol tablet (new and marketed)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: before dosing (0 h) and at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosingMaximum plasma concentration (Cmax)
Outcome measures
| Measure |
Elzsa Film-coated Tablet
n=24 Participants
Participants received Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water
Elzsa film-coated tablet: Administered with 240 mL of water
|
Diane-35 Sugar-coated Tablet
n=24 Participants
Participants received Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water
Diane-35 Sugar-coated tablet: Administered with 240 mL of water
|
|---|---|---|
|
Pharmacokinetics Parameter
Cmax of Cyproterone Acetate
|
17.39 pg/mL
Standard Deviation 13.77
|
16.20 pg/mL
Standard Deviation 13.81
|
|
Pharmacokinetics Parameter
Cmax of Ethinyl Estradiol
|
103.69 pg/mL
Standard Deviation 47.42
|
93.61 pg/mL
Standard Deviation 47.16
|
PRIMARY outcome
Timeframe: before dosing (0 h) and at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosingArea Under Curve from 0 to 72 hours (AUCt)
Outcome measures
| Measure |
Elzsa Film-coated Tablet
n=24 Participants
Participants received Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water
Elzsa film-coated tablet: Administered with 240 mL of water
|
Diane-35 Sugar-coated Tablet
n=24 Participants
Participants received Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water
Diane-35 Sugar-coated tablet: Administered with 240 mL of water
|
|---|---|---|
|
Pharmacokinetics Parameter
AUC0-t of Cyproterone Acetate
|
132.56 pg*hr/mL
Standard Deviation 73.19
|
127.54 pg*hr/mL
Standard Deviation 89.41
|
|
Pharmacokinetics Parameter
AUC0-t of Ethinyl Estradiol
|
870.45 pg*hr/mL
Standard Deviation 383.56
|
842.56 pg*hr/mL
Standard Deviation 398.66
|
Adverse Events
Elzsa Film-coated Tablet
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Diane-35 Sugar-coated Tablet
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Elzsa Film-coated Tablet
n=24 participants at risk
New (test) Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose.
|
Diane-35 Sugar-coated Tablet
n=24 participants at risk
Marketed (reference) Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose.
|
|---|---|---|
|
General disorders
Dizziness
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
8.3%
2/24 • Number of events 2 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
|
General disorders
Drowsiness
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
|
General disorders
Headache
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
8.3%
2/24 • Number of events 2 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
|
Reproductive system and breast disorders
Breast tenderness or Breast discomfort
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
|
General disorders
Toothache
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
0.00%
0/24 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
|
Gastrointestinal disorders
Pharyngitis
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
0.00%
0/24 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
|
Renal and urinary disorders
Frequently Urination
|
0.00%
0/24 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
|
General disorders
Syncope
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
0.00%
0/24 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
|
Respiratory, thoracic and mediastinal disorders
Flu like symptoms (Runny rose nose, headache)
|
0.00%
0/24 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/24 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
4.2%
1/24 • Number of events 1 • at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
\[Not Specified\]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place