Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants

NCTNCT04172987Other id17103Other idI8F-MC-GPGR

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 40 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 26 Feb 2020
Primary completion: 9 Feb 2021
Completion: 9 Feb 2021
First posted: 21 Nov 2019
Last update posted: 27 Mar 2023
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022

Ph 1
A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants
NCT04172987
26 Feb 2020 to 9 Feb 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to look at how the body processes the commonly prescribed birth control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side effects that may occur will also be collected. Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 20 weeks, including screening.

Interventions

TirzepatideDrug
EE/NGMDrug

Arms2

Experimental
Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)
Participants received a 28-day packet of a combination oral contraceptive (OC) containing 21 days of tablets that consist of active ingredients (0.035 mg ethinyl estradiol (EE) and 0.25 mg norgestimate (NGM)) self-administered orally once-daily (QD) on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day.
Experimental
EE/NGM + Tirzepatide (Period 2)
Participants received a 28-day packet of a combination OC containing 21 days of tablets that consist of active ingredients (0.035 mg EE and 0.25 mg NGM) self-administered orally QD on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day and a single dose 5 mg tirzepatide administered subcutaneously (SC).

Primary outcomes4

Outcomes the sponsor listed as primary.

Period 1 and Period 2, Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Ethinylestradiol (EE)
Time frame · Period 1 and Period 2: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
Registry description
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\[0-tau\]) of Ethinylestradiol (EE)
Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EE
Time frame · Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
Registry description
PK: Cmax of EE
Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN)
Time frame · Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
Registry description
PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\[0-tau\]) of Norelgestromin (NGMN)
Period 1 and Period 2, PK: Cmax of Norelgestromin (NGMN)
Time frame · Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
Registry description
PK: Cmax of Norelgestromin (NGMN)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Period 1 and Period 2: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose

Period 1 and Period 2, Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Ethinylestradiol (EE)

Group	Value (picogram hour per milliliter (pg*h/mL))	Spread
OC (0.035 mg EE and 0.25 mg NGM)	966	40
OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide	811	41

Primary outcomeGeometric mean· Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose

Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EE

Group	Value (picogram per milliliter pg/mL)	Spread
OC (0.035 mg EE and 0.25 mg NGM)	119	33
OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide	49.6	63

Primary outcomeGeometric mean· Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose

Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN)

Group	Value (pg*h/mL)	Spread
OC (0.035 mg EE and 0.25 mg NGM)	19900	27
OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide	14600	67

Primary outcomeGeometric mean· Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose

Period 1 and Period 2, PK: Cmax of Norelgestromin (NGMN)

Group	Value (pg/mL)	Spread
OC (0.035 mg EE and 0.25 mg NGM)	2070	27
OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide	892	74

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Lead-in: OC ( 0.035 mg EE and 0.25 mg NGM)Participants received a 28-day packet of a combination oral contraceptive (OC) containing 21 days of tablets that consist of active ingredients (0.035 mg ethinyl estradiol (EE) and 0.25 mg norgestimate (NGM)) self-administered orally once-daily (QD) on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day.	0 / 40	0 / 40	9 / 40
Period 1: OC ( 0.035 mg EE and 0.25 mg NGM)Participants received a 28-day packet of a combination oral contraceptive (OC) containing 21 days of tablets that consist of active ingredients (0.035 mg ethinyl estradiol (EE) and 0.25 mg norgestimate (NGM)) self-administered orally once-daily (QD) on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day.	0 / 38	0 / 38	10 / 38
Period 2: OC ( 0.035 mg EE and 0.25 mg NGM) + 5 mg TirzepatideParticipants received a 28-day packet of a combination OC containing 21 days of tablets that consist of active ingredients (0.035 mg EE and 0.25 mg NGM) self-administered orally QD on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day and a single dose 5 mg tirzepatide administered SC.	0 / 28	0 / 28	18 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Overtly healthy females as determined by medical history, physical examination, and other screening procedures * Have a body mass index (BMI) equal to or above 18.5 kilograms per meter squared (kg/m²), at screening * Are not intending to start a family within 2 months after the study Exclusion Criteria: * Have known allergies to either tirzepatide or ethinylestradiol or norgestimate or related compounds * Have a medical condition or medical history that precludes the taking of combined oral contraceptives * Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors * Have used hormonal implants or received hormonal injections in the past 12 months * Unwilling to comply with smoking restrictions during the study * Is a known user of drugs of abuse

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