A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Combined Oral Contraceptives in Premenopausal Women with Documented Endometriosis and Associated Moderate to Severe Pain. (M18-969)

Purpose

To assess the safety and efficacy of Elagolix (150 mg QD) when used concurrently with a combined oral contraceptive containing an estrogen and a progesterone in premenopausal women with endometriosis and associated moderate to severe pain.

Criteria

Criteria:

1.        Agrees to the washout intervals for hormonal therapies and other medications that require washout.

2.       Must be willing to discontinue use of any prior analgesics or other medical treatments for endometriosis upon entry into Washout or Screening periods and subject must agree to use only protocol-allowed rescue analgesics for her endometriosis associated pain during screening and controlled treatment Periods

3.       Must agree to use dual nonhormonal methods of contraception consistently.

4.       Premenopausal females 18 to 49 years of age (inclusive) at the time of Screening

5.       Must have a negative pregnancy test.

6.       Must have a negative Hepatitis B and Hepatitis C test

7.       Must have a normal pap smear.

8.       Must not be breastfeeding, pregnant, or planning a pregnancy until completion of study participation.

9.       Must be ≥ 6 months post-partum, post-abortion, post-pregnancy, and post-lactation at the time of entry into the Screening Period.

10.    Must have menstrual cycle lengths of 21 to 35 days for 3 consecutive months prior to Screening.

Cycle length should remain at this interval during Screening.

You Cannot

1.       Have surgical history of:

· Hysterectomy

· Bilateral oophorectomy

 · Major surgery (including laparotomy for endometriosis) within 3 months prior to the initial Screening visit

· Minor surgery (including laparoscopy for endometriosis) within 1 month prior to the initial screening visit.

2.       Must not have a copper IUD.

3.       Must not use marijuana.

4.       Must be in general good health

5.       No history of psychiatric disorders.

6.       No osteoporosis or metabolic bone disease.

Details

1.       18-month treatment process

2.       Monthly visits to provider months 4-18.

3.       Study related physician visits and treatment are free of charge.

4.       Study stipend.

Interested in more information on clinical research? Contact WK Health System Clinical Research Department 318-212-8130 or ckay@wkhs.com

Interested in more information? Contact Us:

Greg Phillips, M.D., Principal Investigator

IRB: Advarra Institutional Review Board
IRB Number:
Trial Type: NA
Sponsor: Abbvie