Trial Outcomes & Findings for A Study of LY2216684 in Healthy Females (NCT NCT01373931)
NCT ID: NCT01373931
Last Updated: 2018-10-23
Results Overview
The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Predose up to 24 hours post dose on Day 21
Results posted on
2018-10-23
Participant Flow
This was a randomized, 2-period, 2-sequence crossover study with a lead-in period.
Participant milestones
| Measure |
OC + LY2216684 / OC + Placebo
Lead-in Period: 28 days of Ortho Cyclen \[OC; 21 days of 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo\]
Period 1: OC + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
Period 2: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
|
OC + Placebo / OC + LY2216684
Lead-in Period: 28 days of OC (21 days of 35 mcg ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo)
Period 1: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
Period 2: OC + 18 mg of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
|
|---|---|---|
|
Lead-in Period
STARTED
|
10
|
10
|
|
Lead-in Period
Received at Least 1 Dose of Study Drug
|
8
|
10
|
|
Lead-in Period
COMPLETED
|
8
|
10
|
|
Lead-in Period
NOT COMPLETED
|
2
|
0
|
|
Period 1
STARTED
|
8
|
10
|
|
Period 1
COMPLETED
|
6
|
8
|
|
Period 1
NOT COMPLETED
|
2
|
2
|
|
Period 2
STARTED
|
6
|
8
|
|
Period 2
COMPLETED
|
6
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
OC + LY2216684 / OC + Placebo
Lead-in Period: 28 days of Ortho Cyclen \[OC; 21 days of 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo\]
Period 1: OC + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
Period 2: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
|
OC + Placebo / OC + LY2216684
Lead-in Period: 28 days of OC (21 days of 35 mcg ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo)
Period 1: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
Period 2: OC + 18 mg of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
|
|---|---|---|
|
Lead-in Period
Adverse Event
|
2
|
0
|
|
Period 1
Adverse Event
|
2
|
0
|
|
Period 1
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study of LY2216684 in Healthy Females
Baseline characteristics by cohort
| Measure |
OC + LY2216684 / OC + Placebo
n=10 Participants
Lead-in Period: 28 days of Ortho Cyclen \[OC; 21 days of 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo\]
Period 1: OC + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
Period 2: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
|
OC + Placebo / OC + LY2216684
n=10 Participants
Lead-in Period: 28 days of OC (21 days of 35 mcg ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo)
Period 1: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
Period 2: OC + 18 mg of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
30.7 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose up to 24 hours post dose on Day 21Population: All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze Cmax. Participants were analyzed based on the treatment they received.
The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant.
Outcome measures
| Measure |
OC + LY2216684
n=14 Participants
Ortho Cyclen (OC) + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
|
OC + Placebo
n=16 Participants
OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
|
|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norelgestromin
Ethinyl Estradiol
|
79.0 picograms/milliliter (pg/mL)
Interval 70.0 to 89.1
|
80.9 picograms/milliliter (pg/mL)
Interval 71.8 to 91.2
|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norelgestromin
Norelgestromin
|
1438 picograms/milliliter (pg/mL)
Interval 1301.0 to 1589.0
|
1574 picograms/milliliter (pg/mL)
Interval 1427.0 to 1735.0
|
PRIMARY outcome
Timeframe: Predose up to 24 hours post dose on Day 21Population: All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze tmax. Participants were analyzed based on the treatment they received.
Outcome measures
| Measure |
OC + LY2216684
n=14 Participants
Ortho Cyclen (OC) + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
|
OC + Placebo
n=14 Participants
OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
|
|---|---|---|
|
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norelgestromin
Ethinyl Estradiol
|
2.00 hour (h)
Interval 1.5 to 4.0
|
2.00 hour (h)
Interval 1.5 to 4.0
|
|
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norelgestromin
Norelgestromin
|
3.00 hour (h)
Interval 1.5 to 4.0
|
2.03 hour (h)
Interval 1.5 to 4.07
|
PRIMARY outcome
Timeframe: Predose up to 24 hours post dose on Day 21Population: All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze AUCτ. Participants were analyzed based on the treatment they received.
The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant.
Outcome measures
| Measure |
OC + LY2216684
n=14 Participants
Ortho Cyclen (OC) + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
|
OC + Placebo
n=16 Participants
OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
|
|---|---|---|
|
Area Under the Concentration-Time Curve Over a Dosing Interval (AUCτ) of Ethinyl Estradiol and Norelgestromin
Ethinyl Estradiol
|
888 picograms*hour/milliliter (pg*hr/mL)
Interval 799.0 to 987.0
|
827 picograms*hour/milliliter (pg*hr/mL)
Interval 744.0 to 918.0
|
|
Area Under the Concentration-Time Curve Over a Dosing Interval (AUCτ) of Ethinyl Estradiol and Norelgestromin
Norelgestromin
|
16156 picograms*hour/milliliter (pg*hr/mL)
Interval 14626.0 to 17846.0
|
16079 picograms*hour/milliliter (pg*hr/mL)
Interval 14575.0 to 17738.0
|
Adverse Events
OC Lead-in Period
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
OC + LY2216684
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
OC + Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OC Lead-in Period
n=18 participants at risk
Lead-in Period: 28 days of Ortho Cyclen \[OC; 21 days of 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo\]
|
OC + LY2216684
n=16 participants at risk
OC + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
|
OC + Placebo
n=16 participants at risk
OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.6%
1/18 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/18
|
18.8%
3/16 • Number of events 3
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Piloerection
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Vascular disorders
Flushing
|
0.00%
0/18
|
12.5%
2/16 • Number of events 2
|
0.00%
0/16
|
|
Vascular disorders
Hot flush
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/18
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/18
|
25.0%
4/16 • Number of events 4
|
12.5%
2/16 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
2/18 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
0.00%
0/16
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/18
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Number of events 4
|
0.00%
0/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • Number of events 4
|
37.5%
6/16 • Number of events 6
|
18.8%
3/16 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
6.2%
1/16 • Number of events 2
|
|
General disorders
Asthenia
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Chest discomfort
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Chest pain
|
0.00%
0/18
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/18
|
31.2%
5/16 • Number of events 5
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/18
|
0.00%
0/16
|
12.5%
2/16 • Number of events 2
|
|
Infections and infestations
Gastroenteritis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/16
|
|
Infections and infestations
Hordeolum
|
0.00%
0/18
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/18
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • Number of events 1
|
18.8%
3/16 • Number of events 3
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18
|
43.8%
7/16 • Number of events 13
|
12.5%
2/16 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 4
|
31.2%
5/16 • Number of events 7
|
18.8%
3/16 • Number of events 5
|
|
Nervous system disorders
Lethargy
|
0.00%
0/18
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/18
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18
|
12.5%
2/16 • Number of events 4
|
0.00%
0/16
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Tension headache
|
0.00%
0/18
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Psychiatric disorders
Emotional poverty
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Psychiatric disorders
Panic reaction
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
11.1%
2/18 • Number of events 2
|
0.00%
0/16
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Menstruation irregular
|
11.1%
2/18 • Number of events 2
|
0.00%
0/16
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Metrorrhagia
|
11.1%
2/18 • Number of events 2
|
0.00%
0/16
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
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