Ovulation; Failure or Lack ofPhase 4NCT04060992
Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist at Different Periods of the Menstrual Cycle
A Phase 4 study testing Elagolix 200 MG Oral Tablet [Orilissa] in people with Ovulation; Failure or Lack of, run by University of Southern California.
Trial summary
The purpose of this study is twofold: First, to see if elagolix can suppress gonadotropin and ovarian hormones in the short-term period, when only administered for a 72-hour period. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovulation; Failure or Lack of
- What is being tested?
- Elagolix 200 MG Oral Tablet [Orilissa]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers from USC Fertility
- Documented ovulation with a serum mid-luteal progesterone ≥3pg/mL
- Ovulatory with a 24-35-day cycle
- Ages 18-39
- Body Mass Index (BMI) 18.1-30.0kg/m2
- Consistent condom use for contraception
- Not desiring or seeking pregnancy
Who cannot join
- Allergy to injectable or oral GnRH-antagonist
- FSH ≥ 10 IU/L or LH ≥ 10 IU/L in early follicular phase iii. Known liver disease iv. Known osteoporosis v. Pregnancy vi. Current use of drugs metabolized by the liver enzyme CYP3A, specifically ketoconazole, rifampin, digoxin, oral midazolam, or rosuvastatin.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Can Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist Withstand When Administered at Different Points in the Menstrual Cycle?
The purpose of this study is twofold: First, to see if elagolix can suppress gonadotropin and ovarian hormones in the short-term period, when only administered for a 72-hour period. If elagolix effectively suppresses gonadotropin and ovarian hormones in a timely manner, it could be used to alter aspects of the menstrual cycle, depending on when administered. Second, is there a window for when elagolix functions best? While other studies initiate elagolix at the start of a woman's menstrual cycle, investigators of this study want to determine if administering elagolix at various points in a woman's menstrual cycle alters its ability to suppress gonadal and ovarian hormones.
Read the detailed description
Gonadotropin-releasing hormone (GnRH) and its analogs have been utilized in clinical medicine since the early 1970s. The GnRH analog is more potent with a longer half-life than native GnRH. When administered continuously rather than in a more physiologic pulsatile manner, the initial stimulation of pituitary gonadotrophs is followed by pituitary desensitization1,2. This ultimately leads to inhibition of the pituitary-gonadal axis. This downregulation facilitates the use of GnRH agonists for the treatment of various medical conditions, including precocious puberty, endometriosis, uterine leiomyomata, prostate cancer, and assisted reproductive technology (ART)1,2.
Like GnRH agonists, antagonists of GnRH have proven to efficiently suppress pituitary and ovarian hormone production. However, unlike the agonist, the GnRH-antagonist competitively binds to the GnRH-receptor1,2. The antagonist bypasses the initial flare effect and does not require the initial period of administration for pituitary desensitization of GnRH receptors. As a result, there is rapid prevention of gonadotropin secretion and antagonist effect on the ovary1-4.
In addition to the enhanced efficiency of using a GnRH-antagonist, it has shown to be more tolerable with fewer side effects when compared to the older GnRH agonist1-5. Particularly in ART, GnRH agonists are associated with hot flashes, ovarian cyst formation, and ovarian hyperstimulation syndrome (OHSS)6. Conversely, GnRH antagonists have been shown to significantly reduce the incidence of OHSS, and are not associated with cyst development or hot flashes6. It is important to note that in ART literature, administration of a GnRH-antagonist has been via a subcutaneous injection, formulated as ganirelix, detirelix or cetrotide3-5.
Fluker et al investigated the impact of the subcutaneous GnRH-antagonist on gonadotropin and ovarian hormone production when administered at different points of the menstrual cycle: mid-follicular phase, preovulatory phase, and early luteal phase5. Investigators found that the GnRH-antagonist successfully suppressed gonadotropin hormones irrespective of phase of menstrual cycle. Suppression of ovarian hormones, and particularly suppression of the LH surge, was evident only when the GnRH-antagonist administered in mid-follicular and early luteal phases5.
In an effort to avoid a subcutaneous injection and ease patient administration, an oral GnRH-antagonist has recently been developed: Elagolix. Research has shown that elagolix similarly suppresses gonadotropin and ovarian hormones compared to its injectable formulary7.
Ng et al investigated the pharmacokinetics of elagolix over a 21-day period, while also investigating elagolix's suppression of gonadotropic and ovarian hormones at varying doses when administered during a natural menstrual cycle7. Time to maximum concentration of elagolix was 1.0-1.5 hours, with a half-life of about 4-6 hours. While maximum suppression of follicle stimulating hormone (FSH) and LH occurred in all doses administered, maximum suppression was seen in the elagolix 300mg BID and 400mg BID groups. Rebound to baseline FSH and LH was evident within 24-48 hours from last dose of elagolix. Maximum estradiol suppression was seen when administered at 200mg BID or higher doses, and maximum progesterone suppression was seen in all doses 100mg BID or higher. While elagolix was administered for a 21-day period, the greatest decrease in gonadotropin and ovarian hormone levels was seen in the first three days of administration at any dose7.
Thus far, the Federal Drug Administration (FDA) has approved elagolix for the management of moderate to severe pain associated with endometriosis. Approved regimens include one 150mg tablet once daily or one 200mg tablet twice daily7-10. Like the injectable GnRH antagonist, the oral GnRH antagonist efficiently manages pain symptoms in endometriosis via suppression of estrogen secretion. Estrogen is thought to play a role in the pathophysiology of endometriosis via its stimulatory effects on the endometrium and its stimulatory effects on a woman's inflammatory milieu, both at the local and systemic level10.
While elagolix has been proven to effectively suppress gonadotropin and ovarian hormones, like the injectable GnRH antagonists, elagolix has yet to be used in conditions other than endometriosis, such as in cases of ART7. More specifically, the impact of elagolix in the short-term period for cases of COH has yet to be studied.
Subjectively looking at Ng et al's data, there are sharp declines in FSH, LH, estradiol, and progesterone within the first three days of administering elagolix, and these concentrations continue to decline, but at a less steep slope, from days 4 through day 21 of administration7. It appears that the first three days are crucial to hormonal suppression7.
- Conditions
- Ovulation; Failure or Lack of
- Being tested
- Elagolix 200 MG Oral Tablet [Orilissa]
- Medical subject headings
- Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elagolix 200 MG Oral Tablet [Orilissa]Drug
oral tablet given twice daily
| Study group | Role | What they receive |
|---|---|---|
| Early Follicular Phase | Experimental | Women enrolled will be anywhere from cycle day 1 through 5 of their menstrual cycle and take elagolix 200mg oral tablet BID for 3 days total. Receives: Drug: Elagolix 200 MG Oral Tablet [Orilissa] |
| Late Follicular Phase | Active comparator | Women enrolled will be anywhere from cycle day 8 through 13 of their menstrual cycle and take elagolix 200mg oral tablet BID for 3 days total. Receives: Drug: Elagolix 200 MG Oral Tablet [Orilissa] |
| Luteal Phase | Active comparator | Women enrolled will be anywhere from cycle day 21 through cycle day 26 of their menstrual cycle and take elagolix 200mg oral tablet BID for 3 days total. Receives: Drug: Elagolix 200 MG Oral Tablet [Orilissa] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppression of gonadotropin and pituitary hormones as measured by hormonal assay status post short-term administration of elagolix
Measure serum concentrations of follicle stimulation hormone (FSH), luteinizing hormone (LH), estradiol, progesterone at baseline and throughout three-day course of elagolix
Measured: measured over 4 days
Secondary outcomes (1)
Time interval to next menses
Calculate number of days from elagolix consumption to next menses
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ovulation; Failure or Lack ofStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Observational study design, prospective cohort study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Stanczyk, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060992
- Sponsor's protocol ID
- APP-19-02687
- Status last verified
- Aug 2019
- First submitted
- 7 Aug 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No, data will not be available to other researchers. At the study completion, all patient data will be destroyed in the HIPAA compliant manner.
Publications
Kumar P, Sharma A. Gonadotropin-releasing hormone analogs: Understanding advantages and limitations. J Hum Reprod Sci. 2014 Jul;7(3):170-4. doi: 10.4103/0974-1208.142476.
PubMed 25395741Andreyko JL, Marshall LA, Dumesic DA, Jaffe RB. Therapeutic uses of gonadotropin-releasing hormone analogs. Obstet Gynecol Surv. 1987 Jan;42(1):1-21.
PubMed 3543765Fluker M, Grifo J, Leader A, Levy M, Meldrum D, Muasher SJ, Rinehart J, Rosenwaks Z, Scott RT Jr, Schoolcraft W, Shapiro DB; North American Ganirelix Study Group. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril. 2001 Jan;75(1):38-45. doi: 10.1016/s0015-0282(00)01638-1.
PubMed 11163814Garcia-Velasco JA, Isaza V, Vidal C, Landazabal A, Remohi J, Simon C, Pellicer A. Human ovarian steroid secretion in vivo: effects of GnRH agonist versus antagonist (cetrorelix). Hum Reprod. 2001 Dec;16(12):2533-9. doi: 10.1093/humrep/16.12.2533.
PubMed 11726570Fluker MR, Marshall LA, Monroe SE, Jaffe RB. Variable ovarian response to gonadotropin-releasing hormone antagonist-induced gonadotropin deprivation during different phases of the menstrual cycle. J Clin Endocrinol Metab. 1991 Apr;72(4):912-9. doi: 10.1210/jcem-72-4-912.
PubMed 2005218Depalo R, Jayakrishan K, Garruti G, Totaro I, Panzarino M, Giorgino F, Selvaggi LE. GnRH agonist versus GnRH antagonist in in vitro fertilization and embryo transfer (IVF/ET). Reprod Biol Endocrinol. 2012 Apr 13;10:26. doi: 10.1186/1477-7827-10-26.
PubMed 22500852Ng J, Chwalisz K, Carter DC, Klein CE. Dose-Dependent Suppression of Gonadotropins and Ovarian Hormones by Elagolix in Healthy Premenopausal Women. J Clin Endocrinol Metab. 2017 May 1;102(5):1683-1691. doi: 10.1210/jc.2016-3845.
PubMed 28323948Elagolix (Orilissa)--an oral GnRH antagonist for endometriosis pain. Med Lett Drugs Ther. 2018 Sep 24;60(1556):158-160. No abstract available.
PubMed 30383729Surrey E, Taylor HS, Giudice L, Lessey BA, Abrao MS, Archer DF, Diamond MP, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Singh SS, Rechberger T, Agarwal SK, Duan WR, Schwefel B, Thomas JW, Peloso PM, Ng J, Soliman AM, Chwalisz K. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160. doi: 10.1097/AOG.0000000000002675.
PubMed 29889764Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19.
PubMed 28525302Danis RB, Sriprasert I, Stanczyk FZ, Paulson RJ, Winer SA, Ho JR. Does timing matter when initiating elagolix in a natural menstrual cycle? F S Rep. 2021 May 31;2(3):308-313. doi: 10.1016/j.xfre.2021.05.009. eCollection 2021 Sep.
PubMed 34553156
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist Withstand When Administered at Different Points in the Menstrual Cycle?
- ClinicalTrials.gov ID
- NCT04060992
- Acronym / sponsor ID
- APP-19-02687
- Conditions
- Ovulation; Failure or Lack of
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is twofold: First, to see if elagolix can suppress gonadotropin and ovarian hormones in the short-term period, when only administered for a 72-hour period. If elagolix effectively suppresses gonadotropin and ovarian hormones in a timely manner, it could be used to alter aspects of the menstrual cycle, depending on when administered. Second, is there a window for when elagolix functions best? While other studies initiate elagolix at the start of a woman's menstrual cycle, investigators of this study want to determine if administering elagolix at various points in a woman's menstrual cycle alters its ability to suppress gonadal and ovarian hormones.
Detailed description
Gonadotropin-releasing hormone (GnRH) and its analogs have been utilized in clinical medicine since the early 1970s. The GnRH analog is more potent with a longer half-life than native GnRH. When administered continuously rather than in a more physiologic pulsatile manner, the initial stimulation of pituitary gonadotrophs is followed by pituitary desensitization1,2. This ultimately leads to inhibition of the pituitary-gonadal axis. This downregulation facilitates the use of GnRH agonists for the treatment of various medical conditions, including precocious puberty, endometriosis, uterine leiomyomata, prostate cancer, and assisted reproductive technology (ART)1,2.
Like GnRH agonists, antagonists of GnRH have proven to efficiently suppress pituitary and ovarian hormone production. However, unlike the agonist, the GnRH-antagonist competitively binds to the GnRH-receptor1,2. The antagonist bypasses the initial flare effect and does not require the initial period of administration for pituitary desensitization of GnRH receptors. As a result, there is rapid prevention of gonadotropin secretion and antagonist effect on the ovary1-4.
In addition to the enhanced efficiency of using a GnRH-antagonist, it has shown to be more tolerable with fewer side effects when compared to the older GnRH agonist1-5. Particularly in ART, GnRH agonists are associated with hot flashes, ovarian cyst formation, and ovarian hyperstimulation syndrome (OHSS)6. Conversely, GnRH antagonists have been shown to significantly reduce the incidence of OHSS, and are not associated with cyst development or hot flashes6. It is important to note that in ART literature, administration of a GnRH-antagonist has been via a subcutaneous injection, formulated as ganirelix, detirelix or cetrotide3-5.
Fluker et al investigated the impact of the subcutaneous GnRH-antagonist on gonadotropin and ovarian hormone production when administered at different points of the menstrual cycle: mid-follicular phase, preovulatory phase, and early luteal phase5. Investigators found that the GnRH-antagonist successfully suppressed gonadotropin hormones irrespective of phase of menstrual cycle. Suppression of ovarian hormones, and particularly suppression of the LH surge, was evident only when the GnRH-antagonist administered in mid-follicular and early luteal phases5.
In an effort to avoid a subcutaneous injection and ease patient administration, an oral GnRH-antagonist has recently been developed: Elagolix. Research has shown that elagolix similarly suppresses gonadotropin and ovarian hormones compared to its injectable formulary7.
Ng et al investigated the pharmacokinetics of elagolix over a 21-day period, while also investigating elagolix's suppression of gonadotropic and ovarian hormones at varying doses when administered during a natural menstrual cycle7. Time to maximum concentration of elagolix was 1.0-1.5 hours, with a half-life of about 4-6 hours. While maximum suppression of follicle stimulating hormone (FSH) and LH occurred in all doses administered, maximum suppression was seen in the elagolix 300mg BID and 400mg BID groups. Rebound to baseline FSH and LH was evident within 24-48 hours from last dose of elagolix. Maximum estradiol suppression was seen when administered at 200mg BID or higher doses, and maximum progesterone suppression was seen in all doses 100mg BID or higher. While elagolix was administered for a 21-day period, the greatest decrease in gonadotropin and ovarian hormone levels was seen in the first three days of administration at any dose7.
Thus far, the Federal Drug Administration (FDA) has approved elagolix for the management of moderate to severe pain associated with endometriosis. Approved regimens include one 150mg tablet once daily or one 200mg tablet twice daily7-10. Like the injectable GnRH antagonist, the oral GnRH antagonist efficiently manages pain symptoms in endometriosis via suppression of estrogen secretion. Estrogen is thought to play a role in the pathophysiology of endometriosis via its stimulatory effects on the endometrium and its stimulatory effects on a woman's inflammatory milieu, both at the local and systemic level10.
While elagolix has been proven to effectively suppress gonadotropin and ovarian hormones, like the injectable GnRH antagonists, elagolix has yet to be used in conditions other than endometriosis, such as in cases of ART7. More specifically, the impact of elagolix in the short-term period for cases of COH has yet to be studied.
Subjectively looking at Ng et al's data, there are sharp declines in FSH, LH, estradiol, and progesterone within the first three days of administering elagolix, and these concentrations continue to decline, but at a less steep slope, from days 4 through day 21 of administration7. It appears that the first three days are crucial to hormonal suppression7.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Observational study design, prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Early Follicular Phase | Experimental | Drug: Elagolix 200 MG Oral Tablet [Orilissa]Women enrolled will be anywhere from cycle day 1 through 5 of their menstrual cycle and take elagolix 200mg oral tablet BID for 3 days total. |
| Late Follicular Phase | Active comparator | Drug: Elagolix 200 MG Oral Tablet [Orilissa]Women enrolled will be anywhere from cycle day 8 through 13 of their menstrual cycle and take elagolix 200mg oral tablet BID for 3 days total. |
| Luteal Phase | Active comparator | Drug: Elagolix 200 MG Oral Tablet [Orilissa]Women enrolled will be anywhere from cycle day 21 through cycle day 26 of their menstrual cycle and take elagolix 200mg oral tablet BID for 3 days total. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers from USC Fertility
- Documented ovulation with a serum mid-luteal progesterone ≥3pg/mL
- Ovulatory with a 24-35-day cycle
- Ages 18-39
- Body Mass Index (BMI) 18.1-30.0kg/m2
Key exclusion criteria (2 listed)
- Allergy to injectable or oral GnRH-antagonist
- FSH ≥ 10 IU/L or LH ≥ 10 IU/L in early follicular phase iii. Known liver disease iv. Known osteoporosis v. Pregnancy vi. Current use of drugs metabolized by the liver enzyme CYP3A, specifically ketoconazole, rifampin, digoxin, oral midazolam, or rosuvastatin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elagolix 200 MG Oral Tablet [Orilissa]oral tablet given twice daily | Drug | Early Follicular Phase, Late Follicular Phase, Luteal Phase |
Primary outcome
Suppression of gonadotropin and pituitary hormones as measured by hormonal assay status post short-term administration of elagolix
Time frame: measured over 4 days
Measure serum concentrations of follicle stimulation hormone (FSH), luteinizing hormone (LH), estradiol, progesterone at baseline and throughout three-day course of elagolix
1 secondary outcome
Time interval to next menses
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Results publication: PubMed 25395741Kumar P, Sharma A. Gonadotropin-releasing hormone analogs: Understanding advantages and limitations. J Hum Reprod Sci. 2014 Jul;7(3):170-4. doi: 10.4103/0974-1208.142476.
- Results publication: PubMed 3543765Andreyko JL, Marshall LA, Dumesic DA, Jaffe RB. Therapeutic uses of gonadotropin-releasing hormone analogs. Obstet Gynecol Surv. 1987 Jan;42(1):1-21.
- Results publication: PubMed 11163814Fluker M, Grifo J, Leader A, Levy M, Meldrum D, Muasher SJ, Rinehart J, Rosenwaks Z, Scott RT Jr, Schoolcraft W, Shapiro DB; North American Ganirelix Study Group. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril. 2001 Jan;75(1):38-45. doi: 10.1016/s0015-0282(00)01638-1.
- Results publication: PubMed 11726570Garcia-Velasco JA, Isaza V, Vidal C, Landazabal A, Remohi J, Simon C, Pellicer A. Human ovarian steroid secretion in vivo: effects of GnRH agonist versus antagonist (cetrorelix). Hum Reprod. 2001 Dec;16(12):2533-9. doi: 10.1093/humrep/16.12.2533.
- Results publication: PubMed 2005218Fluker MR, Marshall LA, Monroe SE, Jaffe RB. Variable ovarian response to gonadotropin-releasing hormone antagonist-induced gonadotropin deprivation during different phases of the menstrual cycle. J Clin Endocrinol Metab. 1991 Apr;72(4):912-9. doi: 10.1210/jcem-72-4-912.
- Results publication: PubMed 22500852Depalo R, Jayakrishan K, Garruti G, Totaro I, Panzarino M, Giorgino F, Selvaggi LE. GnRH agonist versus GnRH antagonist in in vitro fertilization and embryo transfer (IVF/ET). Reprod Biol Endocrinol. 2012 Apr 13;10:26. doi: 10.1186/1477-7827-10-26.
- Results publication: PubMed 28323948Ng J, Chwalisz K, Carter DC, Klein CE. Dose-Dependent Suppression of Gonadotropins and Ovarian Hormones by Elagolix in Healthy Premenopausal Women. J Clin Endocrinol Metab. 2017 May 1;102(5):1683-1691. doi: 10.1210/jc.2016-3845.
- Results publication: PubMed 30383729Elagolix (Orilissa)--an oral GnRH antagonist for endometriosis pain. Med Lett Drugs Ther. 2018 Sep 24;60(1556):158-160. No abstract available.
- Results publication: PubMed 29889764Surrey E, Taylor HS, Giudice L, Lessey BA, Abrao MS, Archer DF, Diamond MP, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Singh SS, Rechberger T, Agarwal SK, Duan WR, Schwefel B, Thomas JW, Peloso PM, Ng J, Soliman AM, Chwalisz K. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160. doi: 10.1097/AOG.0000000000002675.
- Results publication: PubMed 28525302Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19.
- Derived from this study: PubMed 34553156Danis RB, Sriprasert I, Stanczyk FZ, Paulson RJ, Winer SA, Ho JR. Does timing matter when initiating elagolix in a natural menstrual cycle? F S Rep. 2021 May 31;2(3):308-313. doi: 10.1016/j.xfre.2021.05.009. eCollection 2021 Sep.
- Individual participant dataSharing planned: No. No, data will not be available to other researchers. At the study completion, all patient data will be destroyed in the HIPAA compliant manner.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elagolix 200 MG Oral Tablet [Orilissa] in people with Ovulation; Failure or Lack of, run by University of Southern California.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel B Danis, MD (5169931812, rachel.danis@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suppression of gonadotropin and pituitary hormones as measured by hormonal assay status post short-term administration of elagolix (time frame: measured over 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04060992, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.