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Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers

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ClinicalTrials.gov Identifier: NCT01253824
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Nobelpharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: NPC-01
Drug: IKH-01
Enrollment 14
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title NPC-01 IKH-01
Hide Arm/Group Description

1mg norethisterone and 0.02mg ethinyl estradiol

NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol

1mg norethisterone and 0.35mg ethinyl estradiol

IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

Period Title: Overall Study
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title NPC-01 IKH-01 Total
Hide Arm/Group Description

1mg norethisterone and 0.02mg ethinyl estradiol

NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol

1mg norethisterone and 0.35mg ethinyl estradiol

IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
All subjects were included for safety and pharmacodynamics analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
26.6  (2.3) 26.1  (4.4) 26.4  (3.4)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 7 participants 7 participants 14 participants
7 7 14
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 7 participants 7 participants 14 participants
51.14  (4.23) 51.86  (6.03) 51.5  (5.01)
1.Primary Outcome
Title 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))
Hide Description 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
Time Frame Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NPC-01 IKH-01
Hide Arm/Group Description:

1mg norethisterone and 0.02mg ethinyl estradiol

NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol

1mg norethisterone and 0.35mg ethinyl estradiol

IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: pg・day/mL,
Difference of estradiol AUC (BL-SDA) 1654.7  (1652.6) 2478.0  (793.0)
Difference of estradiol AUC(FU-SDA) 1872.6  (1819.2) 2434.9  (1151.5)
2.Primary Outcome
Title 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))
Hide Description Progesterone 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
Time Frame Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NPC-01 IKH-01
Hide Arm/Group Description:

1mg norethisterone and 0.02mg ethinyl estradiol

NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol

1mg norethisterone and 0.35mg ethinyl estradiol

IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: ng・day/mL
Difference of progesterone(BL-SDA) 54.171  (25.769) 93.148  (45.867)
Difference of progesterone(FU-SDA) 89.711  (47.882) 59.344  (49.160)
3.Secondary Outcome
Title 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))
Hide Description FSH 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
Time Frame Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NPC-01 IKH-01
Hide Arm/Group Description:

1mg norethisterone and 0.02mg ethinyl estradiol

NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol

1mg norethisterone and 0.35mg ethinyl estradiol

IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: mIU・day/mL
Differnce of FSH (BL-SDA) -9.609  (20.879) -4.380  (18.034)
Difference of FSH(FP-SDA) -4.404  (41.309) 0.538  (30.497)
4.Secondary Outcome
Title 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))
Hide Description LH 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
Time Frame Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NPC-01 IKH-01
Hide Arm/Group Description:

1mg norethisterone and 0.02mg ethinyl estradiol

NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol

1mg norethisterone and 0.35mg ethinyl estradiol

IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: mIU・day/mL
Difference of LH(BL-SDA) 60.874  (41.200) 57.124  (50.821)
Difference of LH(FU-SDA) 61.571  (89.546) 59.837  (25.549)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NPC-01 IKH-01
Hide Arm/Group Description

1mg norethisterone and 0.02mg ethinyl estradiol

NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol

1mg norethisterone and 0.35mg ethinyl estradiol

IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

All-Cause Mortality
NPC-01 IKH-01
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NPC-01 IKH-01
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NPC-01 IKH-01
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/7 (85.71%)      6/7 (85.71%)    
Gastrointestinal disorders     
Abdominal discomfort * 1  0/7 (0.00%)  0 1/7 (14.29%)  1
Abdominal pain * 1  1/7 (14.29%)  1 1/7 (14.29%)  1
Abdominal pain upper * 1  1/7 (14.29%)  1 0/7 (0.00%)  0
Aphthous stomatitis * 1  1/7 (14.29%)  1 0/7 (0.00%)  0
Stomatitis * 1  0/7 (0.00%)  0 1/7 (14.29%)  1
Toothache * 1  1/7 (14.29%)  1 0/7 (0.00%)  0
General disorders     
Feeling hot * 1  1/7 (14.29%)  1 0/7 (0.00%)  0
Infections and infestations     
Nasopharyngitis * 1  2/7 (28.57%)  2 1/7 (14.29%)  1
Pharyngitis * 1  1/7 (14.29%)  1 0/7 (0.00%)  0
Tonsillitis * 1  0/7 (0.00%)  0 1/7 (14.29%)  1
Investigations     
Electrocardiogram QT prolonged  1  1/7 (14.29%)  1 0/7 (0.00%)  0
Plasminogen increased  1  1/7 (14.29%)  1 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal stiffness * 1  1/7 (14.29%)  1 0/7 (0.00%)  0
Nervous system disorders     
Headache * 1  0/7 (0.00%)  0 1/7 (14.29%)  2
Tension headache * 1  1/7 (14.29%)  1 0/7 (0.00%)  0
Reproductive system and breast disorders     
Menorrhagia * 1  0/7 (0.00%)  0 2/7 (28.57%)  2
Metrorrhagia * 1  5/7 (71.43%)  6 3/7 (42.86%)  8
Oligomenorrhoea * 1  2/7 (28.57%)  3 4/7 (57.14%)  4
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA-J 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Department director of clinical development department 1
Organization: Nobelpharama
Phone: +81-23-5651-1177
EMail: murakami@nobelpharma.co.jp
Layout table for additonal information
Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT01253824     History of Changes
Other Study ID Numbers: NPC-01-4
First Submitted: December 2, 2010
First Posted: December 3, 2010
Results First Submitted: April 10, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014