Trial Outcomes & Findings for A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants (NCT NCT01458210)
NCT ID: NCT01458210
Last Updated: 2014-10-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose
Results posted on
2014-10-08
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Lead-in (1st Course of Ortho-Cyclen)
STARTED
|
22
|
|
Lead-in (1st Course of Ortho-Cyclen)
Received at Least One Dose of Study Drug
|
22
|
|
Lead-in (1st Course of Ortho-Cyclen)
COMPLETED
|
22
|
|
Lead-in (1st Course of Ortho-Cyclen)
NOT COMPLETED
|
0
|
|
Ortho-Cyclen Alone (Period 1)
STARTED
|
22
|
|
Ortho-Cyclen Alone (Period 1)
COMPLETED
|
18
|
|
Ortho-Cyclen Alone (Period 1)
NOT COMPLETED
|
4
|
|
Ortho-Cyclen + Dulaglutide (Period 2)
STARTED
|
18
|
|
Ortho-Cyclen + Dulaglutide (Period 2)
COMPLETED
|
15
|
|
Ortho-Cyclen + Dulaglutide (Period 2)
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Ortho-Cyclen Alone (Period 1)
Withdrawal by Subject
|
2
|
|
Ortho-Cyclen Alone (Period 1)
Lost to Follow-up
|
2
|
|
Ortho-Cyclen + Dulaglutide (Period 2)
Withdrawal by Subject
|
2
|
|
Ortho-Cyclen + Dulaglutide (Period 2)
Adverse Event
|
1
|
Baseline Characteristics
A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants
Baseline characteristics by cohort
| Measure |
Overall Study
n=22 Participants
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.
|
|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 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
|
0 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
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 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
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dosePopulation: Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.
Outcome measures
| Measure |
Ortho-Cyclen Alone (Period 1)
n=19 Participants
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.
|
Ortho-Cyclen + Dulaglutide (Period 2)
n=14 Participants
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.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN)
|
17900 picograms*hour/milliliter (pg*h/mL)
Geometric Coefficient of Variation 26
|
16000 picograms*hour/milliliter (pg*h/mL)
Geometric Coefficient of Variation 18
|
PRIMARY outcome
Timeframe: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dosePopulation: Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.
Outcome measures
| Measure |
Ortho-Cyclen Alone (Period 1)
n=19 Participants
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.
|
Ortho-Cyclen + Dulaglutide (Period 2)
n=14 Participants
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.
|
|---|---|---|
|
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Norelgestromin (NGMN)
|
1770 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 24
|
1310 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 30
|
PRIMARY outcome
Timeframe: Day 21 Periods 1 and 2: Pre-dose and up to 24 hours post-dosePopulation: Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.
Outcome measures
| Measure |
Ortho-Cyclen Alone (Period 1)
n=19 Participants
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.
|
Ortho-Cyclen + Dulaglutide (Period 2)
n=14 Participants
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.
|
|---|---|---|
|
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Norelgestromin (NGMN)
|
3.00 hours
Interval 1.0 to 4.0
|
4.00 hours
Interval 1.5 to 6.0
|
PRIMARY outcome
Timeframe: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dosePopulation: Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.
Outcome measures
| Measure |
Ortho-Cyclen Alone (Period 1)
n=19 Participants
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.
|
Ortho-Cyclen + Dulaglutide (Period 2)
n=14 Participants
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.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Ethinyl Estradiol (EE)
|
901 picograms*hour/milliliter (pg*h/mL)
Geometric Coefficient of Variation 23
|
903 picograms*hour/milliliter (pg*h/mL)
Geometric Coefficient of Variation 28
|
PRIMARY outcome
Timeframe: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dosePopulation: Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.
Outcome measures
| Measure |
Ortho-Cyclen Alone (Period 1)
n=19 Participants
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.
|
Ortho-Cyclen + Dulaglutide (Period 2)
n=14 Participants
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.
|
|---|---|---|
|
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Ethinyl Estradiol (EE)
|
86.9 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 22
|
76.2 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 34
|
PRIMARY outcome
Timeframe: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dosePopulation: Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.
Outcome measures
| Measure |
Ortho-Cyclen Alone (Period 1)
n=19 Participants
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.
|
Ortho-Cyclen + Dulaglutide (Period 2)
n=14 Participants
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.
|
|---|---|---|
|
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Ethinyl Estradiol (EE)
|
3.00 hours
Interval 1.0 to 4.0
|
4.00 hours
Interval 1.5 to 6.0
|
Adverse Events
Lead-in (1st Course of Ortho-Cyclen)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ortho-Cyclen Alone
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Ortho-Cyclen + Dulaglutide
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lead-in (1st Course of Ortho-Cyclen)
n=22 participants at risk
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).
|
Ortho-Cyclen Alone
n=22 participants at risk
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).
|
Ortho-Cyclen + Dulaglutide
n=17 participants at risk
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.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/22 • 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.
|
9.1%
2/22 • Number of events 2 • 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.
|
0.00%
0/17 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • 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.
|
9.1%
2/22 • Number of events 7 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/22 • 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.
|
0.00%
0/22 • 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.
|
5.9%
1/17 • Number of events 2 • 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.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/22 • 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.
|
0.00%
0/22 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
|
Eye disorders
Vision blurred
|
4.5%
1/22 • Number of events 1 • 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.
|
0.00%
0/22 • 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.
|
11.8%
2/17 • Number of events 2 • 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.
|
|
Eye disorders
Visual impairment
|
0.00%
0/22 • 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.
|
0.00%
0/22 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/22 • 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.
|
0.00%
0/22 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • 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.
|
0.00%
0/22 • 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.
|
11.8%
2/17 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
2/22 • Number of events 2 • 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.
|
0.00%
0/22 • 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.
|
0.00%
0/17 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • 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.
|
13.6%
3/22 • Number of events 3 • 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.
|
41.2%
7/17 • Number of events 7 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • 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.
|
4.5%
1/22 • Number of events 1 • 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.
|
35.3%
6/17 • Number of events 14 • 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.
|
|
General disorders
Asthenia
|
4.5%
1/22 • Number of events 1 • 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.
|
0.00%
0/22 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
|
Infections and infestations
Pharyngitis
|
4.5%
1/22 • Number of events 1 • 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.
|
9.1%
2/22 • Number of events 2 • 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.
|
0.00%
0/17 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
1/22 • Number of events 1 • 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.
|
0.00%
0/22 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • 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.
|
4.5%
1/22 • Number of events 1 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22 • 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.
|
4.5%
1/22 • Number of events 1 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • 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.
|
13.6%
3/22 • Number of events 3 • 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.
|
0.00%
0/17 • 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.
|
|
Nervous system disorders
Headache
|
9.1%
2/22 • Number of events 2 • 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.
|
36.4%
8/22 • Number of events 10 • 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.
|
41.2%
7/17 • Number of events 7 • 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.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/22 • 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.
|
0.00%
0/22 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/22 • 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.
|
4.5%
1/22 • Number of events 1 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/22 • 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.
|
9.1%
2/22 • Number of events 2 • 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.
|
0.00%
0/17 • 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.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
4.5%
1/22 • Number of events 1 • 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.
|
9.1%
2/22 • Number of events 2 • 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.
|
0.00%
0/17 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/22 • 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.
|
9.1%
2/22 • Number of events 2 • 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.
|
0.00%
0/17 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/22 • 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.
|
13.6%
3/22 • Number of events 3 • 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.
|
0.00%
0/17 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/22 • 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.
|
13.6%
3/22 • Number of events 3 • 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.
|
0.00%
0/17 • 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.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60