HealthyPhase 1NCT05613777

A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood

A Phase 1 study testing Microgynon® and Iclepertin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The main objective of this trial is to investigate the possible effect of multiple oral doses of BI 425809 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (administered as the combined oral contraceptive Microgynon®). Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Microgynon® and Iclepertin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteGermany
Study dates: 24 Nov 2022to 4 Oct 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy premenopausal female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure(BP), Pulse rate (PR)), 12-lead Electrocardiogram (12-lead ECG), and clinical laboratory tests without any clinically significant abnormalities.
Age of 18 to 35 years (inclusive).
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive).
Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Female subjects who meet any of the following criteria starting from at least 30 days before the first administration of BI 425809 and until 30 days after trial completion:
Use of adequate contraception, e.g. non-hormonal intrauterine device plus condom.

Show all 9Show fewer

Sexually abstinent.
A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment).
Surgically sterilised (including hysterectomy).

Who cannot join

Subjects will not be allowed to participate, if any of the following general criteria apply:
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm).
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.

Show all 9Show fewer

Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair).
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
History of relevant orthostatic hypotension, fainting spells, or blackouts. Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Germany1 site

CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167

Other trials in Germany

About this study

Official title: The Effect of Multiple Doses of BI 425809 on the Pharmacokinetics of Multiple Doses of a Combination of Ethinylestradiol and Levonorgestrel Following Oral Administration in Healthy Premenopausal Female Subjects (an Open-label, Two-period, Fixed Sequence Design Trial With run-in Period)

Conditions: Healthy
Being tested: Microgynon®, Iclepertin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Microgynon®Drug
ethinylestradiol (EE) and levonorgestrel (LNG)
IclepertinDrug
Also called BI 425809
Iclepertin

Study groups in NCT05613777
Study group	Role	What they receive
Microgynon® (R), then Microgynon® + Iclepertin (T)	Experimental	Not described Receives: Drug: Microgynon®; Drug: Iclepertin

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
This outcome measured the area under the concentration-time curve of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Measured: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
Area Under the Concentration-time Curve of Levonogestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
This outcome measured the area under the concentration-time curve of levonogestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Measured: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
Maximum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
This outcome measured the maximum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Measured: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
Maximum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
This outcome measured the maximum measured concentration of levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Measured: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
Minimum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )
This outcome measured the minimum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Measured: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
Minimum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )
This outcome measured the minimum measured concentration of Levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Measured: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 20224 Oct 2023

First posted14 Nov 2022
Study start24 Nov 2022
Primary completion4 Oct 2023
Study completion4 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Fixed sequence: Run in period-Reference-Treatment
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05613777
Sponsor's protocol ID: 1346-0036
Other IDs: 2022-500050-42-00
Status last verified: Apr 2026
First submitted: 7 Nov 2022
Last updated: 6 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Publications

Madari S, Balavarca Y, Shatillo Y, Reuteman-Fowler C, Desch M. The Effect of Multiple Oral Doses of a Glycine Transporter 1 Inhibitor, Iclepertin (BI 425809), on the Steady-state Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel: a Phase I Clinical Trial in Healthy Females. Clin Drug Investig. 2025 Oct;45(10):767-779. doi: 10.1007/s40261-025-01472-5. Epub 2025 Sep 4.
PubMed 40906309

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Multiple Doses of BI 425809 on the Pharmacokinetics of Multiple Doses of a Combination of Ethinylestradiol and Levonorgestrel Following Oral Administration in Healthy Premenopausal Female Subjects (an Open-label, Two-period, Fixed Sequence Design Trial With run-in Period)
ClinicalTrials.gov ID: NCT05613777
Acronym / sponsor ID: 1346-0036
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 24 Nov 2022 (actual)
Primary completion: 4 Oct 2023 (actual)
Study completion: 4 Oct 2023 (actual)
First posted: 14 Nov 2022 (actual)
Results: Posted 6 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Fixed sequence: Run in period-Reference-Treatment

Arm	Type	Receives
Microgynon® (R), then Microgynon® + Iclepertin (T)	Experimental	Drug: Microgynon®, Drug: Iclepertin

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Healthy premenopausal female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure(BP), Pulse rate (PR)), 12-lead Electrocardiogram (12-lead ECG), and clinical laboratory tests without any clinically significant abnormalities.
Age of 18 to 35 years (inclusive).
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive).
Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Female subjects who meet any of the following criteria starting from at least 30 days before the first administration of BI 425809 and until 30 days after trial completion:

Key exclusion criteria (9 listed)

Subjects will not be allowed to participate, if any of the following general criteria apply:
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm).
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
Any evidence of a concomitant disease assessed as clinically relevant by the investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Microgynon®ethinylestradiol (EE) and levonorgestrel (LNG)	Drug	Microgynon® (R), then Microgynon® + Iclepertin (T)
IclepertinAlso: BI 425809Iclepertin	Drug	Microgynon® (R), then Microgynon® + Iclepertin (T)

Primary outcome

Area Under the Concentration-time Curve of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Time frame: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the area under the concentration-time curve of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Area Under the Concentration-time Curve of Levonogestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Time frame: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the area under the concentration-time curve of levonogestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Maximum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
Time frame: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the maximum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Maximum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
Time frame: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the maximum measured concentration of levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Minimum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )
Time frame: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the minimum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Minimum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )
Time frame: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the minimum measured concentration of Levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.

Results and safety

Results posted to the registry on 6 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Microgynon® (R), Then Microgynon® + Iclepertin (T)	17	17

Primary outcome: Area Under the Concentration-time Curve of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)

Time frame: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.. Geometric least squares mean (Standard Error). Unit: hour*picogram/milliliter

Measure	Microgynon® (R) n = 17	Microgynon® + Iclepertin (T) n = 14
Value	916.63 (NA)	942.17 (NA)

Microgynon® (R) vs Microgynon® + Iclepertin (T): Adjusted gMean ratio (%): 102.79 (90% CI 92.86 to 113.77)

Population analysed: Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Primary outcome: Area Under the Concentration-time Curve of Levonogestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)

Measure	Microgynon® (R) n = 17	Microgynon® + Iclepertin (T) n = 14
Value	102541.7 (NA)	106443.0 (NA)

Microgynon® (R) vs Microgynon® + Iclepertin (T): Adjusted gMean ratio (%): 103.80 (90% CI 97.62 to 110.38)

Primary outcome: Maximum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)

Measure	Microgynon® (R) n = 17	Microgynon® + Iclepertin (T) n = 14
Value	91.44 (NA)	94.32 (NA)

Microgynon® (R) vs Microgynon® + Iclepertin (T): Adjusted gMean ratio (%): 103.16 (90% CI 93.64 to 113.64)

Primary outcome: Maximum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)

Measure	Microgynon® (R) n = 17	Microgynon® + Iclepertin (T) n = 14
Value	8841.40 (NA)	9388.81 (NA)

Microgynon® (R) vs Microgynon® + Iclepertin (T): Adjusted gMean ratio (%): 106.19 (90% CI 100.66 to 112.03)

Adverse events

Time frame: Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Microgynon® (Run-in)	0 of 18 (0%)	12 of 18 (66.7%)	0 of 18
Microgynon® (R)	0 of 17 (0%)	13 of 17 (76.5%)	0 of 17
Microgynon® + Iclepertin (T)	0 of 17 (0%)	15 of 17 (88.2%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40906309Madari S, Balavarca Y, Shatillo Y, Reuteman-Fowler C, Desch M. The Effect of Multiple Oral Doses of a Glycine Transporter 1 Inhibitor, Iclepertin (BI 425809), on the Steady-state Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel: a Phase I Clinical Trial in Healthy Females. Clin Drug Investig. 2025 Oct;45(10):767-779. doi: 10.1007/s40261-025-01472-5. Epub 2025 Sep 4.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Microgynon® and Iclepertin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) (time frame: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05613777, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.