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TerminatedNCT01941615Updated Apr 11, 2016Results posted

Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel

A Phase 1 interventional study of faldaprevir and Microgynon® in Healthy, sponsored by Boehringer Ingelheim. Terminated at 1 site in Germany. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-11.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

Browse Boehringer Ingelheim studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy female subjects
  • Age 18 to 35 years (inclusive)
  • Body Mass Index 20-29.9 kg/m2
  • Use of hormonal contraception (i.e. oral contraceptives, hormonal contraceptive vaginal ring, but not hormone-containing intrauterine devices, depot injections or contraceptive implants)

Exclusion criteria

Exclusion criteria:

  • Any relevant deviation from healthy conditions
  • Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
  • Positive pregnancy test, pregnancy or planning to become pregnant within 1 month of study completion, or lactation
  • Any relevant finding of the gynaecological examination
  • Thrombotic predisposition according to thrombophilic testing
  • Existing or history of arterial thrombotic or embolic processes, conditions which predispose to them e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation
  • Existing or history of confirmed venous thromboembolism, family history of venous thromboembolism, and other known risk factors for venous thromboembolism.
  • Relevant varicosis
  • No use of an additional contraceptive method from screening examination until 1 month after last study drug administration (acceptable methods are considered to be barrier methods, sexual abstinence, non-hormone-containing intrauterine device, or vasectomisation for the male partner).

Use of hormone-containing intrauterine device, depot injection or contraceptive implants

  • Any history of relevant liver diseases (e.g. disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, or previous or existing liver tumours)
  • AST (aspartate transaminase) and/or ALT (alanine transaminase) > 1.5 ULN (upper limit of normal)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    BI 207127 + faldaprevir + Microgynon

    Period A: Microgynon®; Period B: Microgynon® + FDV + BI 207127

    Drug: faldaprevir · Drug: Microgynon® · Drug: BI 207127

Interventions

  • Drugfaldaprevir

    oral doses for 10 days (period B)

  • DrugMicrogynon®

    oral doses for 23 days (period A+B)

  • DrugBI 207127

    oral doses for 10 days (period B)

06

What researchers measure

Primary outcomes

  1. AUCtau,ss of Ethinylestradiol

    Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).

    Time frame: 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

  2. Cmax,ss of Ethinylestradiol

    Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t

    Time frame: 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

  3. C24,ss of Ethinylestradiol

    Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration.

    Time frame: 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

  4. AUCtau,ss of Levonogestrel

    Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t.

    Time frame: 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

  5. Cmax,ss of Levonogestrel

    Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t.

    Time frame: 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

  6. C24,ss of Levonogestrel

    Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration.

    Time frame: 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

07

Results

Posted Apr 11, 2016
Limitations and caveats
This trial was prematurely discontinued during the run-in period. During the run-in period, subjects were to receive Microgynon® once daily for 21 to 49 days. The investigational products Deleobuvir + faldaprevir were not administered.

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.

Run in Treatment: Microgynon®
Participant flow — Run in Treatment: Microgynon®
MilestoneDeleobuvir + Faldaprevir + Microgynon
Started16
Completed16
Not completed0
Reference Treatment: Microgynon®
Participant flow — Reference Treatment: Microgynon®
MilestoneDeleobuvir + Faldaprevir + Microgynon
Started0
Completed0
Not completed0
Microgynon® Plus Deleobuvir+Faldaprevir
Participant flow — Microgynon® Plus Deleobuvir+Faldaprevir
MilestoneDeleobuvir + Faldaprevir + Microgynon
Started0
Completed0
Not completed0

Outcome measures

PrimaryAUCtau,ss of Ethinylestradiol

Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).

Time frame:
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

No measurements were reported for this outcome.

PrimaryCmax,ss of Ethinylestradiol

Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t

Time frame:
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

No measurements were reported for this outcome.

PrimaryC24,ss of Ethinylestradiol

Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration.

Time frame:
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

No measurements were reported for this outcome.

PrimaryAUCtau,ss of Levonogestrel

Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t.

Time frame:
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

No measurements were reported for this outcome.

PrimaryCmax,ss of Levonogestrel

Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t.

Time frame:
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

No measurements were reported for this outcome.

PrimaryC24,ss of Levonogestrel

Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration.

Time frame:
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

No measurements were reported for this outcome.

Adverse events

Collected over until end of run-in period up to 49 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Deleobuvir + Faldaprevir + Microgynon—0/16 (0%)4/16 (25%)
Most frequent other events
Most frequent other events
EventDeleobuvir + Faldaprevir + Microgynon
MetrorrhagiaReproductive system and breast disorders2/16
NasopharyngitisInfections and infestations1/16
ArthralgiaMusculoskeletal and connective tissue disorders1/16
HeadacheNervous system disorders1/16
Breast painReproductive system and breast disorders1/16
Uterine painReproductive system and breast disorders1/16

Baseline characteristics

Age, Continuous
Age, Continuous(years)Deleobuvir + Faldaprevir + Microgynon
Mean26.5 ± 3.7
Sex: Female, Male
Sex: Female, Male(Participants)Deleobuvir + Faldaprevir + Microgynon
Female16
Male0
08

Study locations

1 site
  • 1241.31.2 Boehringer Ingelheim Investigational Site
    Mannheim, Germany
09

References and documents

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01941615
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Sep 13, 2013
Start date
Nov 2013
Primary completion
Jan 2014
Completion
Jan 2014
Results posted
Apr 11, 2016
Last update
Apr 11, 2016

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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