Trial Outcomes & Findings for The Role of Estrogen in Luteinizing Hormone Surge and Ovulation (NCT NCT01999569)
NCT ID: NCT01999569
Last Updated: 2022-04-22
Results Overview
Serum progesterone ng/mL drawn during cycle days twelve through 22
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
Cycle days 12-22
Results posted on
2022-04-22
Participant Flow
Ovulatory volunteers
Participant milestones
| Measure |
Control Then Letrozole
Control cycle. Then letrozole cycle
|
|---|---|
|
Control Cycle
STARTED
|
10
|
|
Control Cycle
COMPLETED
|
10
|
|
Control Cycle
NOT COMPLETED
|
0
|
|
Letrozole Treatment Cycle
STARTED
|
10
|
|
Letrozole Treatment Cycle
COMPLETED
|
10
|
|
Letrozole Treatment Cycle
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Estrogen in Luteinizing Hormone Surge and Ovulation
Baseline characteristics by cohort
| Measure |
Control
n=10 Participants
Control cycle. Then letrozole cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Cycle days 12-22Serum progesterone ng/mL drawn during cycle days twelve through 22
Outcome measures
| Measure |
Control
n=10 Participants
Control cycle
|
Letrozole Treatment Cycle
n=10 Participants
|
|---|---|---|
|
Number of Participants With Progesterone Level Greater Than 1.5 ng/mL
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Cycle days 10-18Urine ovulation tests assessed
Outcome measures
| Measure |
Control
n=10 Participants
Control cycle
|
Letrozole Treatment Cycle
n=10 Participants
|
|---|---|---|
|
Number of Participants With a Positive LH Test
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Cycle day 12Ovulation; elevated progesterone
Outcome measures
| Measure |
Control
n=10 Participants
Control cycle
|
Letrozole Treatment Cycle
n=10 Participants
|
|---|---|---|
|
Number of Participants With Follicular Development
|
10 Participants
|
10 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Letrozole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bradley Hurst, M.D., Director of Assisted Reproduction
Carolinas Healthcare System
Phone: 704-355-3149
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place