A Pharmacokinetic Study of Colchicine With an Oral Contraceptive

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT01040845
First received: August 13, 2009
Last updated: December 30, 2009
Last verified: December 2009
Results First Received: August 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Pharmacokinetics
Interventions: Drug: Norethindrone/Ethinyl Estradiol
Drug: Colchicine
Drug: Placebo (for Colchicine)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty (30) healthy, non-smoking, premenopausal adult female volunteers, consisting of university students and members of the community at large, were to be enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
51 subjects screened, 21 were screen failures

Reporting Groups
  Description
Oral Contraceptive With Placebo Then Colchicine [All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (matching placebo capsule during the first cycle or over-encapsulated colchicine tablets 0.6 mg during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
Oral Contraceptive With Colchicine Then Placebo [All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (over-encapsulated colchicine tablets 0.6 mg during or matching placebo capsule during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.

Participant Flow:   Overall Study
    Oral Contraceptive With Placebo Then Colchicine     Oral Contraceptive With Colchicine Then Placebo  
STARTED     15     15  
COMPLETED     13 [1]   14 [2]
NOT COMPLETED     2     1  
Withdrawal by Subject                 1                 1  
Physician Decision                 1                 0  
[1] withdrew consent due to schedule conflict (1); dropped by physician due to positive drug screen (1)
[2] withdrew consent due to schedule conflict (1)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Oral Contraceptive With Placebo Then Colchicine All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
Oral Contraceptive With Colchicine Then Placebo All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
Total Total of all reporting groups

Baseline Measures
    Oral Contraceptive With Placebo Then Colchicine     Oral Contraceptive With Colchicine Then Placebo     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age [1]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     15     30  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  23.8  ± 7.9     23.9  ± 4.2     23.9  ± 6.3  
Gender  
[units: participants]
     
Female     15     15     30  
Male     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     15     15     30  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  
[1] age range: >=18 and <=45



  Outcome Measures
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1.  Primary:   Maximum Plasma Concentration of Norethindrone With Colchicine at Steady State (Cmax, ss)   [ Time Frame: Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose. ]

2.  Primary:   Maximum Plasma Concentration of Norethindrone With Placebo at Steady State (Cmax, ss)   [ Time Frame: Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose. ]

3.  Primary:   Maximum Plasma Concentration of Ethinyl Estradiol With Colchicine at Steady State (Cmax, ss)   [ Time Frame: Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose. ]

4.  Primary:   Maximum Plasma Concentration of Ethinyl Estradiol With Placebo at Steady State (Cmax, ss)   [ Time Frame: Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose. ]

5.  Primary:   Maximum Plasma Concentration of Colchicine With Norethindrone/Ethinyl Estradiol at Steady State (Cmax, ss)   [ Time Frame: Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose ]

6.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Colchicine   [ Time Frame: Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose. ]

7.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Placebo   [ Time Frame: Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose. ]

8.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Ethinyl Estradiol With Colchicine   [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration. ]

9.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Ethinyl Estradiol With Placebo   [ Time Frame: Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose. ]

10.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colchicine With Norethindrone/Ethinyl Estradiol   [ Time Frame: Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Mutual Pharmaceutical Company, Inc.
phone: 215-697-1743
e-mail: clinicaltrials@urlmutual.com


No publications provided


Responsible Party: Vice President Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT01040845     History of Changes
Other Study ID Numbers: MPC-004-07-1005
Study First Received: August 13, 2009
Results First Received: August 13, 2009
Last Updated: December 30, 2009
Health Authority: United States: Food and Drug Administration