Pilot E2 for Hypogonadal Women With CFBD

• Status: Withdrawn
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study is a prospective, double blinded, placebo controlled, randomized study to evaluate the effects of daily oral estrogen supplements on bone health, sexual and reproductive health, quality of life and markers of inflammation and lung function when given to hypogonadal women with Cystic Fibrosis related Bone Disease (CFBD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Adult and adolescent female CF patients (age ≥ 18 years),

• presenting to the CF clinic for routine follow up of cystic fibrosis,

• hypogonadal women defined as E2 level < 25,

• dual energy X-ray absorptiometry (DEXA) scan within 2 years of enrollment with T- or Z-score < -1,

• able to tolerate oral medications.

Exclusion Criteria:

• Inability to obtain or declined informed consent from the subject and/or legally authorized representative,

• Pregnancy,

• Too ill to participate in study based on investigator's or study team's opinion,

• Current use of systemic estrogen,

• History of thromboembolic event within the previous 2 years,

• History of migraines with aura,

• Hypercoagulability including previous diagnosis of Factor V Leiden or Protein C or S deficiency,

• Current smoker,

• History of diagnosis with breast or uterine cancer,

• Current significant liver disease with cholelithiasis or cirrhosis,

• Status post lung or liver transplantation,

• Current use of systemic steroids