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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-GBCQ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to look at how the body processes oral contraceptive (OC), using Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the body. Information about any side effects that may occur will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ortho-Cyclen (OC) Alone (Period 1); OC+Dulaglutide (Period 2) | Experimental | Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course and the Period 2 sample was taken during the second 28-day course. Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ortho-Cyclen | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN) | Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose | |
| Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Norelgestromin (NGMN) | Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose | |
| Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Norelgestromin (NGMN) | Day 21 Periods 1 and 2: Pre-dose and up to 24 hours post-dose | |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Ethinyl Estradiol (EE) | Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose | |
| Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Ethinyl Estradiol (EE) | Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose | |
| Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Ethinyl Estradiol (EE) | Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose |
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Inclusion Criteria:
Are females of child-bearing potential, and who are overtly healthy as determined by medical history and physical examination
Have a body mass index (BMI) of between 18.5 and 30.0 kilogram-meter squared (kg/m^2), at screening
Have no clinically significant findings, as determined by the investigator, upon bimanual pelvic and breast examinations, at screening (provision of previous gynecological examination documentation may be accepted)
Have clinical laboratory test results within the normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow for blood sampling
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and restrictions
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dallas | Texas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28357715 | Derived | de la Pena A, Cui X, Geiser J, Loghin C. No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. Clin Pharmacokinet. 2017 Nov;56(11):1415-1427. doi: 10.1007/s40262-017-0531-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lead-in (1st Course of Ortho-Cyclen) |
| ||||||||||||||||
| Ortho-Cyclen Alone (Period 1) |
| ||||||||||||||||
| Ortho-Cyclen + Dulaglutide (Period 2) |
|
Participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN) | Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data. | Geometric Mean | Geometric Coefficient of Variation | picograms*hour/milliliter (pg*h/mL) | Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose |
|
Ortho-Cyclen alone includes Period 1 and Day 1 through Day 18 (before the administration of dulaglutide) in Period 2. Ortho-Cyclen + Dulaglutide includes from Day 19 (postdose of dulaglutide) in Period 2 through the end of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lead-in (1st Course of Ortho-Cyclen) | Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| C555680 | dulaglutide |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Dulaglutide |
| Biological |
Administered subcutaneously |
|
|
| United States |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Ortho-Cyclen + Dulaglutide (Period 2) | Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course. Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2. |
|
|
| Primary | Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Norelgestromin (NGMN) | Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data. | Geometric Mean | Geometric Coefficient of Variation | picograms per milliliter (pg/mL) | Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Norelgestromin (NGMN) | Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data. | Median | Full Range | hours | Day 21 Periods 1 and 2: Pre-dose and up to 24 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Ethinyl Estradiol (EE) | Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data. | Geometric Mean | Geometric Coefficient of Variation | picograms*hour/milliliter (pg*h/mL) | Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Ethinyl Estradiol (EE) | Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data. | Geometric Mean | Geometric Coefficient of Variation | picograms per milliliter (pg/mL) | Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Ethinyl Estradiol (EE) | Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data. | Median | Full Range | hours | Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose |
|
|
|
| 0 |
| 22 |
| 5 |
| 22 |
| EG001 | Ortho-Cyclen Alone | Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). | 0 | 22 | 14 | 22 |
| EG002 | Ortho-Cyclen + Dulaglutide | Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2. | 0 | 17 | 11 | 17 |
| Vision blurred | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |