Trial Outcomes & Findings for A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood (NCT NCT05934942)
NCT ID: NCT05934942
Last Updated: 2025-02-24
Results Overview
TERMINATED
PHASE1
29 participants
Planned: pre-dose within 10 minutes before 1st drug administration, and then in period 1 and period 2 post-dose : 480:30, 481:00, 481:30, 482:00, 482:30, 483:00, 483:30, 484:00, 485:00, 486:00, 488:00, 490:00, 492:00, 504:00 hours (h)
2025-02-24
Participant Flow
This was a non-randomized, open-label, two-period, fixed-sequence trial involving a run-in phase. The study treated 28 healthy female participants with Yasmin® in the run-in period and aimed to compare Yasmin® (reference treatment) with the combination of Yasmin® and BI 1358894 (test treatment).
29 female participants of child-bearing potential who met all inclusion and no exclusion criteria entered the study, 28 were treated with Yasmin® , 1 was not treated, and 1 withdrew. 27 participants completed the run-in period. No female participant received an investigational medicinal treatment in Period 1 (Yasmin® alone) or Period 2 (Yasmin® and BI 1358894). The study was prematurely discontinued as per protocol in the run-in period.
Participant milestones
| Measure |
Yasmin® (Reference Treatment) Followed by BI 1358894 and Yasmin® (Test Treatment)
All female participants were treated with 1 daily tablet of the contraceptive Yasmin® (ethinylestradiol and drospirenone) during the run-in period (Day-56 to Day-8).
The study was discontinued as per protocol in the run-in period, and thus none of the participants received the planned treatments for period 1 (reference treatment (R)) and for period 2 (test treatment (T)).
Period 1: The planned reference treatment was to administer one tablet of Yasmin® daily after a continental breakfast on Days 1-21 of period 1 (not administered).
Period 2: The planned test treatment consisted of one tablet of Yasmin®, one tablet of BI 1358894 25 milligram (mg) and two tablets of BI 1358894 50 mg (for a total dose of BI 1358894 = 125mg) each administered daily after a continental breakfast on Days 1-21 in period 2 (not administered).
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|---|---|
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Run-in Period
STARTED
|
29
|
|
Run-in Period
COMPLETED
|
27
|
|
Run-in Period
NOT COMPLETED
|
2
|
|
Period 1 - Reference Treatment
STARTED
|
0
|
|
Period 1 - Reference Treatment
COMPLETED
|
0
|
|
Period 1 - Reference Treatment
NOT COMPLETED
|
0
|
|
Period 2 - Test Treatment
STARTED
|
0
|
|
Period 2 - Test Treatment
COMPLETED
|
0
|
|
Period 2 - Test Treatment
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Yasmin® (Reference Treatment) Followed by BI 1358894 and Yasmin® (Test Treatment)
All female participants were treated with 1 daily tablet of the contraceptive Yasmin® (ethinylestradiol and drospirenone) during the run-in period (Day-56 to Day-8).
The study was discontinued as per protocol in the run-in period, and thus none of the participants received the planned treatments for period 1 (reference treatment (R)) and for period 2 (test treatment (T)).
Period 1: The planned reference treatment was to administer one tablet of Yasmin® daily after a continental breakfast on Days 1-21 of period 1 (not administered).
Period 2: The planned test treatment consisted of one tablet of Yasmin®, one tablet of BI 1358894 25 milligram (mg) and two tablets of BI 1358894 50 mg (for a total dose of BI 1358894 = 125mg) each administered daily after a continental breakfast on Days 1-21 in period 2 (not administered).
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|---|---|
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Run-in Period
Not treated
|
1
|
|
Run-in Period
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
Baseline characteristics by cohort
| Measure |
Yasmin® (Reference Treatment) Followed by BI 1358894 and Yasmin® (Test Treatment)
n=28 Participants
All female participants were treated with 1 daily tablet of the contraceptive Yasmin® (ethinylestradiol and drospirenone) during the run-in period (Day-56 to Day-8).
The study was discontinued as per protocol in the run-in period, and thus none of the participants received the planned treatments for period 1 (reference treatment (R)) and for period 2 (test treatment (T)).
Period 1: The planned reference treatment was to administer one tablet of Yasmin® daily after a continental breakfast on Days 1-21 of period 1 (not administered).
Period 2: The planned test treatment consisted of one tablet of Yasmin®, one tablet of BI 1358894 25 milligram (mg) and two tablets of BI 1358894 50 mg (for a total dose of BI 1358894 = 125mg) each administered daily after a continental breakfast on Days 1-21 in period 2 (not administered).
|
|---|---|
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Age, Customized
|
30 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Planned: pre-dose within 10 minutes before 1st drug administration, and then in period 1 and period 2 post-dose : 480:30, 481:00, 481:30, 482:00, 482:30, 483:00, 483:30, 484:00, 485:00, 486:00, 488:00, 490:00, 492:00, 504:00 hours (h)Population: The study was prematurely discontinued as per protocol after run-in period. No pharmacokinetic (PK) parameter values were collected. Therefore, the PK parameter analysis set as defined in the protocol was not applicable.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Planned: pre-dose within 10 minutes before 1st drug administration, and then in period 1 and period 2 post-dose : 480:30, 481:00, 481:30, 482:00, 482:30, 483:00, 483:30, 484:00, 485:00, 486:00, 488:00, 490:00, 492:00, 504:00 hours (h)Population: The study was prematurely discontinued as per protocol after run-in period. No pharmacokinetic (PK) parameter values were collected. Therefore, the PK parameter analysis set as defined in the protocol was not applicable.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Planned: pre-dose within 10 minutes before 1st drug administration, and then in period 1 and period 2 post-dose : 480:30, 481:00, 481:30, 482:00, 482:30, 483:00, 483:30, 484:00, 485:00, 486:00, 488:00, 490:00, 492:00, 504:00 hours (h)Population: The study was prematurely discontinued as per protocol after run-in period. No pharmacokinetic (PK) parameter values were collected. Therefore, the PK parameter analysis set as defined in the protocol was not applicable.
Outcome measures
Outcome data not reported
Adverse Events
Yasmin® (run-in Period)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Yasmin® (run-in Period)
n=28 participants at risk
All female participants were treated with 1 daily tablet of the contraceptive Yasmin® (ethinylestradiol and drospirenone) during the run-in period (Day-56 to Day-8).
Since the study was discontinued as per protocol in the run-in period, none of the participants received the intended treatments for periods 1 and 2.
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|---|---|
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Infections and infestations
Nasopharyngitis
|
10.7%
3/28 • Run-in period (Yasmin® only): Adverse events and all-cause mortality: From first Yasmin® administration on Day -56 until last administration of Yasmin® on Day -8 plus 9 days (residual effect period), up to 57 days.
Treated set: All subjects who were entered to the trial and received Yasmin® during the run-in period.
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|
Nervous system disorders
Headache
|
14.3%
4/28 • Run-in period (Yasmin® only): Adverse events and all-cause mortality: From first Yasmin® administration on Day -56 until last administration of Yasmin® on Day -8 plus 9 days (residual effect period), up to 57 days.
Treated set: All subjects who were entered to the trial and received Yasmin® during the run-in period.
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|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
7.1%
2/28 • Run-in period (Yasmin® only): Adverse events and all-cause mortality: From first Yasmin® administration on Day -56 until last administration of Yasmin® on Day -8 plus 9 days (residual effect period), up to 57 days.
Treated set: All subjects who were entered to the trial and received Yasmin® during the run-in period.
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Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee 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