Trial Outcomes & Findings for A Study of AZD4901 in Females With Polycystic Ovary Syndrome (NCT NCT01872078)
NCT ID: NCT01872078
Last Updated: 2015-10-12
Results Overview
Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose \[AUC(0-8)\] at Day 7
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Day 7
Results posted on
2015-10-12
Participant Flow
67 patients were recruited to the study, of which 65 received doses of AZD4901 between 20 mg qd and 40 mg bid or placebo. Two patients were excluded due to poor venous access
Participant milestones
| Measure |
Placebo
Two matching placebo tablets for both the morning and evening doses
|
20 mg AZD4901 Once Daily
One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
|
20 mg AZD4901 Twice Daily
One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
|
40 mg AZD4901 Twice Daily
Two 20-mg AZD4901 tablets for both the morning and evening doses
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
17
|
17
|
|
Overall Study
COMPLETED
|
16
|
15
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Two matching placebo tablets for both the morning and evening doses
|
20 mg AZD4901 Once Daily
One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
|
20 mg AZD4901 Twice Daily
One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
|
40 mg AZD4901 Twice Daily
Two 20-mg AZD4901 tablets for both the morning and evening doses
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Dose administration non-compliance
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Patient met exclusion criterion 16.
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of AZD4901 in Females With Polycystic Ovary Syndrome
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Two matching placebo tablets for both the morning and evening doses
|
20 mg AZD4901 Once Daily
n=15 Participants
One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
|
20 mg AZD4901 Twice Daily
n=17 Participants
One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
|
40 mg AZD4901 Twice Daily
n=17 Participants
Two 20-mg AZD4901 tablets for both the morning and evening doses
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27 Years
STANDARD_DEVIATION 3 • n=5 Participants
|
29 Years
STANDARD_DEVIATION 6 • n=7 Participants
|
27 Years
STANDARD_DEVIATION 6 • n=5 Participants
|
28 Years
STANDARD_DEVIATION 6 • n=4 Participants
|
28 Years
STANDARD_DEVIATION 6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 7Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose \[AUC(0-8)\] at Day 7
Outcome measures
| Measure |
Placebo
n=13 Participants
Two matching placebo tablets for both the morning and evening doses
|
20 mg AZD4901 qd
n=13 Participants
20 mg AZD4901 once daily administered orally
|
20 mg AZD4901 Bid
n=14 Participants
20 mg AZD4901 twice daily administered orally
|
40 mg AZD4901 Bid
n=15 Participants
40 mg AZD4901 twice daily administered orally
|
|---|---|---|---|---|
|
Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7
|
1.118 Ratio
Interval 0.8446 to 1.479
|
0.9729 Ratio
Interval 0.7351 to 1.288
|
0.8804 Ratio
Interval 0.6724 to 1.153
|
0.5364 Ratio
Interval 0.4134 to 0.696
|
Adverse Events
20 mg AZD4901 Once Daily
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
20 mg AZD4901 Twice Daily
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
40 mg AZD4901 Twice Daily
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
20 mg AZD4901 Once Daily
n=15 participants at risk
One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
|
20 mg AZD4901 Twice Daily
n=17 participants at risk
One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
|
40 mg AZD4901 Twice Daily
n=17 participants at risk
Two 20-mg AZD4901 tablets for both the morning and evening doses
|
Placebo
n=16 participants at risk
Two matching placebo tablets for both the morning and evening doses
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
Other adverse events
| Measure |
20 mg AZD4901 Once Daily
n=15 participants at risk
One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
|
20 mg AZD4901 Twice Daily
n=17 participants at risk
One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
|
40 mg AZD4901 Twice Daily
n=17 participants at risk
Two 20-mg AZD4901 tablets for both the morning and evening doses
|
Placebo
n=16 participants at risk
Two matching placebo tablets for both the morning and evening doses
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
General disorders
Nodule
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
2/15
|
5.9%
1/17
|
5.9%
1/17
|
6.2%
1/16
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Nervous system disorders
Headache
|
13.3%
2/15
|
17.6%
3/17
|
23.5%
4/17
|
31.2%
5/16
|
|
Nervous system disorders
Migraine
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Nervous system disorders
Presyncope
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Nervous system disorders
Syncope
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/15
|
5.9%
1/17
|
5.9%
1/17
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15
|
11.8%
2/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15
|
0.00%
0/17
|
5.9%
1/17
|
6.2%
1/16
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15
|
0.00%
0/17
|
0.00%
0/17
|
6.2%
1/16
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
|
Infections and infestations
Appendicitis
|
0.00%
0/15
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
6.7%
1/15
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/15
|
0.00%
0/17
|
0.00%
0/17
|
6.2%
1/16
|
|
General disorders
Influenza Like Illness
|
0.00%
0/15
|
0.00%
0/17
|
5.9%
1/17
|
6.2%
1/16
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
6.7%
1/15
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Investigations
Hepatic Enzyme Increased
|
13.3%
2/15
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/15
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/15
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Pelvic Pain
|
6.7%
1/15
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/15
|
0.00%
0/17
|
0.00%
0/17
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.7%
1/15
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
|
Eye disorders
Conjunctivitis
|
6.7%
1/15
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/15
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
|
Vascular disorders
Hot Flush
|
0.00%
0/15
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
|
General disorders
Pyrexia
|
0.00%
0/15
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AstraZeneca will manage the publication of the results of the Clinical Trial in partnership with the authors. AstraZeneca recognises that Institutions/Investigators may wish to make publications regarding Clinical Trial results. The Institution/Investigator agrees to collaborate in good faith with AstraZeneca. Prior to any such publication, the Institution/Investigator shall provide AstraZeneca with preliminary data and drafts of proposed publications.
- Publication restrictions are in place
Restriction type: OTHER