Trial Outcomes & Findings for Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers (NCT NCT01253824)
NCT ID: NCT01253824
Last Updated: 2025-03-06
Results Overview
Estradiol was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
14 participants
Primary outcome timeframe
Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
Results posted on
2025-03-06
Participant Flow
Fifty one subjects were screened for this study after acquiring an informed consent. 18 subjects of those participated in pre-medication menstrual cycle phase to confirm baseline of estradiol, progesterone, FSH and LH. 4 subjects withdrew IC during this phase, therefore, 14 subjects were registered and allocated study drugs.
Participant milestones
| Measure |
NPC-01
1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
|
IKH-01
1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers
Baseline characteristics by cohort
| Measure |
NPC-01
n=7 Participants
1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
|
IKH-01
n=7 Participants
1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.6 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
26.1 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
26.4 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Body weight
|
51.14 kg
STANDARD_DEVIATION 4.23 • n=5 Participants
|
51.86 kg
STANDARD_DEVIATION 6.03 • n=7 Participants
|
51.5 kg
STANDARD_DEVIATION 5.01 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cyclesEstradiol was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data
Outcome measures
| Measure |
NPC-01
n=7 Participants
1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
|
IKH-01
n=7 Participants
1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
|
|---|---|---|
|
Comparing Estradiol AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))
Difference of estradiol AUC (BL-SDA)
|
1654.7 pg･day/mL,
Standard Deviation 1652.6
|
2478.0 pg･day/mL,
Standard Deviation 793.0
|
|
Comparing Estradiol AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))
Difference of estradiol AUC(FU-SDA)
|
1872.6 pg･day/mL,
Standard Deviation 1819.2
|
2434.9 pg･day/mL,
Standard Deviation 1151.5
|
PRIMARY outcome
Timeframe: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cyclesProgesterone was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data
Outcome measures
| Measure |
NPC-01
n=7 Participants
1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
|
IKH-01
n=7 Participants
1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
|
|---|---|---|
|
Comparing Progesterone AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))
Difference of progesterone(BL-SDA)
|
54.171 ng･day/mL
Standard Deviation 25.769
|
93.148 ng･day/mL
Standard Deviation 45.867
|
|
Comparing Progesterone AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))
Difference of progesterone(FU-SDA)
|
89.711 ng･day/mL
Standard Deviation 47.882
|
59.344 ng･day/mL
Standard Deviation 49.160
|
SECONDARY outcome
Timeframe: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cyclesFSH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data
Outcome measures
| Measure |
NPC-01
n=7 Participants
1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
|
IKH-01
n=7 Participants
1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
|
|---|---|---|
|
Comparing FSH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))
Differnce of FSH (BL-SDA)
|
-9.609 mIU･day/mL
Standard Deviation 20.879
|
-4.380 mIU･day/mL
Standard Deviation 18.034
|
|
Comparing FSH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))
Difference of FSH(FP-SDA)
|
-4.404 mIU･day/mL
Standard Deviation 41.309
|
0.538 mIU･day/mL
Standard Deviation 30.497
|
SECONDARY outcome
Timeframe: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cyclesLH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data
Outcome measures
| Measure |
NPC-01
n=7 Participants
1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
|
IKH-01
n=7 Participants
1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
|
|---|---|---|
|
Comparing LH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))
Difference of LH(BL-SDA)
|
60.874 mIU･day/mL
Standard Deviation 41.200
|
57.124 mIU･day/mL
Standard Deviation 50.821
|
|
Comparing LH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))
Difference of LH(FU-SDA)
|
61.571 mIU･day/mL
Standard Deviation 89.546
|
59.837 mIU･day/mL
Standard Deviation 25.549
|
Adverse Events
NPC-01
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
IKH-01
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NPC-01
n=7 participants at risk
1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
|
IKH-01
n=7 participants at risk
1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
28.6%
2/7 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
|
Nervous system disorders
Tension headache
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/7
|
28.6%
2/7 • Number of events 2
|
|
Reproductive system and breast disorders
Metrorrhagia
|
71.4%
5/7 • Number of events 6
|
42.9%
3/7 • Number of events 8
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
28.6%
2/7 • Number of events 3
|
57.1%
4/7 • Number of events 4
|
|
General disorders
Feeling hot
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Electrocardiogram QT prolonged
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Plasminogen increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
Additional Information
Department director of clinical development department 1
Nobelpharama
Phone: +81-23-5651-1177
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the sponsor and PI that no restricts the PI's right but need to discuss the timing of publish date of trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER