Endometriosis Clinical Trial
Official title:
Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix
Orilissa is a drug approved for the management of moderate to severe pain associated with endometriosis. Oriahnn is approved for heavy menstrual bleeding due to uterine fibroids. Elagolix-containing products should not be taken by women who are pregnant or suspected to be pregnant but pregnancies are expected as the medicine does not completely stop ovulation and women may inadvertently continue taking Elagolix-containing products until their pregnancy is confirmed. This study will assess pregnancy outcomes (maternal, fetal, and infant) of participants with and without exposure to Elagolix-containing products for their endometriosis or other conditions based on approved indications and prescribing patterns of Elagolix. Around 584 participants will be enrolled (292 participants exposed to Elagolix and 292 without exposure) in the United States. Participants will not receive Elagolix-containing products as part of this study but will be followed for maternal and fetal outcomes up to 1 year after delivery. There may be a higher burden for participants in this study compared to standard of care. Participants will be asked to provide additional information by questionnaire during each trimester of pregnancy, and at 0-6 weeks, 26 weeks, and 1 year after delivery. Contact Bloom Pregnancy Call Center at 1-833-782-7241 or bloompregnancyregistry@iqvia.com or visit https://www.bloompregnancyregistry.com/.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01931670 -
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
|
Phase 3 | |
Recruiting |
NCT05648669 -
A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
|
Phase 3 | |
Completed |
NCT04081532 -
The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain
|
N/A | |
Recruiting |
NCT06101303 -
Endometriosis Pain
|
||
Completed |
NCT04665414 -
Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
|
||
Completed |
NCT03690765 -
Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
|
||
Recruiting |
NCT05153512 -
ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
|
||
Active, not recruiting |
NCT04171297 -
Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
|
||
Recruiting |
NCT04172272 -
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures
|
N/A | |
Completed |
NCT04565470 -
Strategies of Self-management of Endometriosis Symptoms
|
||
Completed |
NCT03613298 -
Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.
|
N/A | |
Withdrawn |
NCT05568940 -
Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
|
||
Not yet recruiting |
NCT03464799 -
Does Immunotherapy Have a Role in the Management of Endometriosis?
|
||
Active, not recruiting |
NCT03002870 -
Characteristics of Patient Population With Endometriosis
|
N/A | |
Completed |
NCT02973854 -
Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
|
||
Withdrawn |
NCT03272360 -
Endometriosis Biomarker Discovery Study
|
N/A | |
Recruiting |
NCT02481739 -
Laparoscopic Surgical Management of Endometriosis on Fertility
|
N/A | |
Active, not recruiting |
NCT02754648 -
Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve
|
N/A | |
Completed |
NCT06106932 -
GnRH-a on Angiogenesis of Endometriosis
|
N/A | |
Completed |
NCT02387931 -
Supplementation in Adolescent Girls With Endometriosis
|
Phase 4 |