Trial Outcomes & Findings for Elagolix for Fertility Enhancement Clinical Trial (NCT NCT04039204)

NCT ID: NCT04039204

Last Updated: 2024-07-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Month 9
• Results posted on: 2024-07-26

Participant Flow

Participant milestones

Measure	Elagolix Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months. Elagolix: This orally active, reversible GnRH antagonist will be used to suppress endometriosis by lowering estrogen levels for 2 months prior to FET	Oral Contraceptives (Ortho Cyclen) Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills. Ortho Cyclen: Oral contraceptive prescribed by physician.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Elagolix Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months. Elagolix: This orally active, reversible GnRH antagonist will be used to suppress endometriosis by lowering estrogen levels for 2 months prior to FET	Oral Contraceptives (Ortho Cyclen) Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills. Ortho Cyclen: Oral contraceptive prescribed by physician.
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Elagolix for Fertility Enhancement Clinical Trial

Baseline characteristics by cohort

Measure	Elagolix n=5 Participants Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months. Elagolix: This orally active, reversible GnRH antagonist will be used to suppress endometriosis by lowering estrogen levels for 2 months prior to FET	Oral Contraceptives (Ortho Cyclen) n=5 Participants Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills. Ortho Cyclen: Oral contraceptive prescribed by physician.	Total n=10 Participants Total of all reporting groups
Age, Continuous	36.9699175 years STANDARD_DEVIATION 3.894399758 • n=5 Participants	32.417758 years STANDARD_DEVIATION 3.606106781 • n=7 Participants	34.44094 years STANDARD_DEVIATION 4.236217486 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 9

Outcome measures

Measure	Elagolix n=5 Participants Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months. Elagolix: This orally active, reversible GnRH antagonist will be used to suppress endometriosis by lowering estrogen levels for 2 months prior to FET	Oral Contraceptives (Ortho Cyclen) n=3 Participants Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills. Ortho Cyclen: Oral contraceptive prescribed by physician.
Number of Live Births	3 live births	1 live births

SECONDARY outcome

Timeframe: week 15

Population: Out of three participants who had embryo transfers in Ortho Cyclen arm, two had viable pregnancies. One of those two had a live birth and one of those two had a miscarriage. So only two participants were analyzed in the Ortho Cyclen arm for this outcome.

The number of subjects with a first trimester pregnancy loss

Outcome measures

Measure	Elagolix n=5 Participants Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months. Elagolix: This orally active, reversible GnRH antagonist will be used to suppress endometriosis by lowering estrogen levels for 2 months prior to FET	Oral Contraceptives (Ortho Cyclen) n=2 Participants Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills. Ortho Cyclen: Oral contraceptive prescribed by physician.
Number of Miscarriages	2 miscarriages	1 miscarriages

SECONDARY outcome

Timeframe: 12 to 15 weeks

Outcome measures

Measure	Elagolix n=5 Participants Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months. Elagolix: This orally active, reversible GnRH antagonist will be used to suppress endometriosis by lowering estrogen levels for 2 months prior to FET	Oral Contraceptives (Ortho Cyclen) n=3 Participants Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills. Ortho Cyclen: Oral contraceptive prescribed by physician.
Number of Viable Pregnancies	5 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 15

nanostring arrays for both miRNAs and inflammation biomarkers

Outcome measures

Outcome data not reported

Adverse Events

Elagolix

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Contraceptives (Ortho Cyclen)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Elagolix n=5 participants at risk Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months. Elagolix: This orally active, reversible GnRH antagonist will be used to suppress endometriosis by lowering estrogen levels for 2 months prior to FET	Oral Contraceptives (Ortho Cyclen) n=5 participants at risk Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills. Ortho Cyclen: Oral contraceptive prescribed by physician.
Reproductive system and breast disorders Abnormal uterine bleeding	0.00% 0/5 • baseline through month 9	40.0% 2/5 • Number of events 2 • baseline through month 9

Additional Information

Bruce Lessey, Ph.D., M.D.

Wake Forest University School of Medicine

Phone: 336-713-0380

Email: blessey@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place