Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

All Drugs and Chemicals

Hormones

Elagolix 25 mg taken orally BID plus placebo

Elagolix 50 mg taken orally QD plus placebo

Elagolix 75 mg taken orally BID plus placebo

Elagolix 150 mg taken orally QD plus placebo

Elagolix 300 mg taken orally QD plus placebo

Elagolix

Placebo

ABBVIE INC.

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).

This is a phase 2, multicenter, double-blind (sponsor-unblinded), randomized, placebo-controlled study to assess the safety and efficacy of elagolix in women with PCOS. PCOS is one of the most common hormonal disorders in women of reproductive age, yet few treatment options are available. This study will help determine if elagolix can impact disordered hormonal dynamics in women with PCOS and at what dosage.

Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.

AbbVie

Elagolix 25 mg BID

Elagolix 50 mg QD

Elagolix 75 mg BID

Elagolix 150 mg QD

Elagolix 300 mg QD

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Body Mass Index (BMI)

Global Medical Services

Across the strata, 90% confidence interval (CI) for adjusted difference and p-value were calculated according to the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.

Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.

Full Analysis Set: all randomly assigned participants who have received at least one dose of study drug in this study. Based on observed cases only.

Percentage of Menstrual Cycle Responders

P-value is from mixed-effect model repeated measure (MMRM) with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.

P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.

Full Analysis Set: all randomly assigned participants who have received at least one dose of study drug in this study. Participants with an assessment.

Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1

Overall Study

Skin and Connective Tissue Diseases

Hemorrhage

Leiomyoma

Myofibroma

Menorrhagia

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Uterine Hemorrhage

Uterine Diseases

Menstruation Disturbances

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.

A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Responders were defined as participants meeting the following 2 conditions:

* menstrual blood loss (MBL) volume \< 80 mL at the Final Month (defined as the last 28 days prior to and including the last dose day), and
* 50% or greater reduction in MBL volume from Baseline to the Final Month.

Participants whose primary reason for prematurely discontinuing study drug was "lack of efficacy," or "requires surgery or invasive intervention for treatment of uterine fibroids" were considered as non-responders. MBL was measured by the alkaline hematin method.

Elagolix 150 mg

White

Black or African American

Asian

Race/Ethnicity, Customized

Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month

Treatment Period

Post-Treatment Follow-Up Period

Reproductive Control Agents

Norethindrone

Norethindrone Acetate

Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Participants prescribed Oriahnn for management of heavy menstrual bleeding (HMB) due to uterine fibroids (UF).

Participants prescribed Oriahnn for management of HMB due to UF, with meaningful hair loss.

Uterine Fibroids (UF) are benign smooth muscle neoplasms of the uterus that affect women of reproductive age. UFs are one of the leading causes of hospitalizations for gynecological disorders and often lead to hysterectomy. In this study, women with heavy menstrual bleeding (HMB) due to UF who are being treated with Oriahnn will be followed to establish the incidence rate, time to onset, extent, pattern, and resolution of meaningful hair loss, as well as any racial differences.

Oriahnn is an approved drug for the management of HMB associated with UF. All study participants will receive Oriahnn as prescribed by their study doctor in accordance with approved local label. Study Participants will be followed for up 24 months (part 1). Approximately 1600 participants aged 18-50 years will be enrolled at 1 site in the United States.

Participants will receive oral Oriahnn as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for 24 months.

There is expected to be no additional burden for participants in this trial. Participants will complete questionnaires on a quarterly basis.

A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

A Prospective, Single-Arm, Descriptive Observational Study to Evaluate Changes in Hair in Women Exposed to Oriahnn® (Elagolix 300 mg BID With Estradiol 1 mg/Norethindrone Acetate 0.5 mg QD)

Meaningful hair loss is defined as patient-reported changes in thickness, fullness, or pattern of hair that results in less hair than normal or hair shedding that is increased from normal in the Hair Questionnaire.

Time from initiation of Oriahnn until patient-reported meaningful hair loss will be assessed.

Based on example description and images of alopecia subtypes, changes in patterns of hair loss are classified as primary pattern of hair loss.

Defined as a report that since the participant has reported hair loss, her hair loss has improved.

Resolution in hair loss is defined as a report that since the patient has reported hair loss, her hair has returned to normal.

Time from onset of meaningful hair loss until reported resolution.

Discontinuations of Oriahnn at or after reported hair loss will be calculated.

Rare Diseases

Adenoma

Cushing Syndrome

Adrenocortical Adenoma

Neoplasms, Glandular and Epithelial

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Adrenocortical Hyperfunction

Cushing's Syndrome

Adenoma of the Adrenal Gland

Hyperadrenalism

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Vasoconstrictor Agents

Respiratory System Agents

Herbal and Botanical

Dexamethasone

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Epinephrine

Dexamethasone acetate

Racepinephrine

Epinephryl borate

Mace

Nutmeg

Post-menopausal women with benign appearing adrenal adenomas, absence of clinical features of overt Cushing's signs or symptoms and MACE confirmed on either 24 hr urine free cortisol (UFC), late night salivary cortisol and/or abnormal dexamethasone suppression

Patients will be given Elagolix 200 mg orally twice daily for a total of 6 months

Eva L Alba

Rachel Sheskier, MD

Alice C Levine

The purpose of this research study is to determine if treatment with Elagolix will improve body weight, waist circumference, muscle strength, cortisol secretion, blood glucose, cholesterol, and bone quality as well as mood and quality of life in a female patient with mild hypercortisolism from adrenal overproduction of cortisol. Many people with adrenal nodules, or non-cancerous growths in the adrenal glands, have mildly elevated cortisol levels. Cortisol is a hormone normally made by the adrenal glands. It is increasingly being recognized that even mild elevations in cortisol levels can negatively impact blood glucose levels, serum cholesterol levels, weight and other metabolic parameters. This can lead to an increase in risk for cardiovascular disease. The study team is trying to determine if the medication Elagolix might be an effective treatment for post-menopausal females with mild hypercortisolism. Elagolix is a medication used to treat a medical condition called endometriosis by decreasing the body's production of sex hormones. Growth of adrenal adenomas is thought to be driven by such sex hormones. Therefore, by decreasing production of these hormones, the study team hopes to treat hypercortisolism caused by adrenal adenomas.

An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women

Cortisol level after dexamethasone suppression test which measures whether adrenocorticotrophic hormone (ACTH) secretion by the pituitary can be suppressed.

24 hour urine free cortisol measurements. The cortisol urine test measures the level of cortisol in the urine. Cortisol is a glucocorticoid (steroid) hormone produced by the adrenal gland.

All patients will have baseline imaging (CT or MRI) within 6 months to start of treatment and then will have repeat imaging with CT abdomen without contrast at 6 months to determine the effect of elagolix treatment on adrenal adenoma size and imaging characteristics. The images will be reviewed by a dedicated adrenal radiologist for consistency.

waist circumference is measured in inches

Vertebral fractures rates will be assessed by lateral X-rays of thoracic and lumbar spine.

The Cushing's Quality of Life Questionnaire is converted to a 0-100 scale in which 0 indicates the worse and 100 the best possible quality of life.

Beck's Depression Scale is scored on a scale of 1 or 40+ where the higher score indicates severe or extreme depression.

The State Trait Anxiety Inventory gives a score range from 6-24 with the higher score indicating a higher level of anxiety.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome	NCT03951077	Polycystic Ovar...	Elagolix Placebo	18 Years - 35 Years	AbbVie
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women	NCT03886220	Uterine Fibroid...	Elagolix Placebo	18 Years - 51 Years	AbbVie
A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)	NCT06058728	Uterine Fibroid...		18 Years - 50 Years	AbbVie
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women	NCT03886220	Uterine Fibroid...	Elagolix Placebo	18 Years - 51 Years	AbbVie
A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)	NCT06058728	Uterine Fibroid...		18 Years - 50 Years	AbbVie
An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women	NCT05038878	Mild Autonomous...	Elagolix	-	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for elagolix

Every month we try and update this database with for elagolix cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for elagolix

Every month we try and update this database with for elagolix cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for elagolix cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.