Trial Outcomes & Findings for Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel (NCT NCT01941615)
NCT ID: NCT01941615
Last Updated: 2016-04-11
Results Overview
Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).
TERMINATED
PHASE1
18 participants
Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives
2016-04-11
Participant Flow
This trial was planned to include 18 healthy premenopausal female subjects. Because this trial was prematurely discontinued during the run-in period, only 16 subjects were entered.
Participant milestones
| Measure |
Deleobuvir + Faldaprevir + Microgynon
This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
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|---|---|
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Run in Treatment: Microgynon®
STARTED
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16
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Run in Treatment: Microgynon®
COMPLETED
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16
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Run in Treatment: Microgynon®
NOT COMPLETED
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0
|
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Reference Treatment: Microgynon®
STARTED
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0
|
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Reference Treatment: Microgynon®
COMPLETED
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0
|
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Reference Treatment: Microgynon®
NOT COMPLETED
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0
|
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Microgynon® Plus Deleobuvir+Faldaprevir
STARTED
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0
|
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Microgynon® Plus Deleobuvir+Faldaprevir
COMPLETED
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0
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Microgynon® Plus Deleobuvir+Faldaprevir
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel
Baseline characteristics by cohort
| Measure |
Deleobuvir + Faldaprevir + Microgynon
n=16 Participants
This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
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|---|---|
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Age, Continuous
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26.5 years
STANDARD_DEVIATION 3.7 • n=5 Participants
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Sex: Female, Male
Female
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16 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptivesPopulation: Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.
Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptivesPopulation: Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.
Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptivesPopulation: Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.
Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptivesPopulation: Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.
Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptivesPopulation: Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.
Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptivesPopulation: Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.
Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration.
Outcome measures
Outcome data not reported
Adverse Events
Deleobuvir + Faldaprevir + Microgynon
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Deleobuvir + Faldaprevir + Microgynon
n=16 participants at risk
In the run-in period starting between Day -56 and Day -28, all subjects were to take 1 Microgynon® tablet (combined oral contraceptive ethinylestradiol / levonorgestrel) once daily for 21 to 49 days (depending on the menstrual cycle) until Day -8.
In the last 7 days of the run-in period (Day -7 to Day -1), no treatment was given in order to induce withdrawal bleeding. The next day was to be Day 1 of the study. Subjects who were using oral contraceptives before the study started the run-in period after the usual tablet-free interval of 7 days.
Subjects who were using hormonal contraceptive vaginal rings before the study started the run-in-period after the usual hormone-free interval of 7 days.
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|---|---|
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Infections and infestations
Nasopharyngitis
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6.2%
1/16 • until end of run-in period up to 49 days
study was terminated after run-in period
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Musculoskeletal and connective tissue disorders
Arthralgia
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6.2%
1/16 • until end of run-in period up to 49 days
study was terminated after run-in period
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Nervous system disorders
Headache
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6.2%
1/16 • until end of run-in period up to 49 days
study was terminated after run-in period
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Reproductive system and breast disorders
Breast pain
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6.2%
1/16 • until end of run-in period up to 49 days
study was terminated after run-in period
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Reproductive system and breast disorders
Metrorrhagia
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12.5%
2/16 • until end of run-in period up to 49 days
study was terminated after run-in period
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Reproductive system and breast disorders
Uterine pain
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6.2%
1/16 • until end of run-in period up to 49 days
study was terminated after run-in period
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Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER