Uterine Fibroids Primrose Study

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

TX155359
  • Ages 18-100
  • Female

Study Summary

To demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women

Eligibility Criteria

Inclusion

Inclusion criteria

  1.        Premenopausal female aged 18 years or above at screening

  2.        Menstrual cycles ≥ 21 days and ≤ 40 days

  3.        Experienced heavy menstrual bleeding (heavy or lasting more than 5 days)

  4.        Subject is willing to use/collect sanitary protection

  5.        Subject agrees to one of the following birth control methods: sexual abstinence, condom or partner with a vasectomy 6 months prior

  6.        If of non-childbearing potential, the subject must have had tubal ligation sterilization or ESSURE 2 months prior to screening visit

Exclusion

Exclusion criteria**

  1.        Subject is pregnant, breast-feeding or planning a pregnancy during the study 

  2.        Hysterectomy or total ovariectomy

  3.        Myomectomy or endometrial ablation, uterine artery embolization or MRgFUS/HIFUS 6 months prior

  4.        Significant finding at the breast examination or on the PAP smear 

  5.        History of or current uterine, cervical, ovarian, breast cancer or any estrogen dependent neoplasia

  6.        Endometrium atypical hyperplasia or adenocarcinoma prior to screening

  7.        Calcified myomas and/or calcified uterus

  8.        Severe coagulation disorder (hemophilia or Von Willebrand)

  9.        Subject has an IUD (can be included one month after IUD removal)

  10.     Failed treatment for uterine fibroids with GnRH agonists or GnRH antagonists

  11.     Used the following medications: combined contraceptives/progestins (1 month prior), depot contraceptives (10 months prior), SPRMs/SERMs (3 months prior), systemic glucocorticoid treatments (1 month prior), acetylsalicylic acid/mefenamic acid/anticoagulants or antifibrinolytic drugs

  12.     Not willing to stop oral contraceptives or other sex hormones

  13.     History of systemic glucocorticoid therapy (SLE, rheumatoid arthritis)

  14.     History of osteoporosis or other metabolic bone disease

  15.     Positive HIV or viral hepatitis serology

  16.     Alcohol or drug abuse

  17.     Active deep vain thrombosis, pulmonary embolism, stroke or hypersensitivity to the ingredients

  18.     Administered any experimental drug 12 weeks prior to dosing

Study Design

Study Start date:
Estimated Completion Date:

Study Description

For more information please call (504) 455-1310 or (985) 900-2400. We have offices located in Metairie and Covington.