Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients

NCT00698035 | Completed Phase 2 Results

• 1 other identifier: UCSF-067519
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients. This study will also evaluate if either of these treatments can improve symptoms of vaginal dryness or decreased sexual interest that are related to your treatment for breast cancer.

Conditions

Sexual Dysfunction, Physiological

Keywords

Vaginal Testosterone Cream; ESTRING

Outcome Measures

Primary Outcomes (1)

• Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range

  Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol \>10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was \>10 pg/dl, subsequent levels \>10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.

  12 Weeks

Secondary Outcomes (6)

• Serum Estradiol (E2)

  12 weeks

• Matched E2 by Commercial and Research (RIA) Analyses

  baseline, 4 weeks

• Total Testosterone Levels

  12 weeks

• Sexual Quality of Life

  Baseline, Week 4, Week 12

• Sexual Satisfaction

  Baseline, Week 4, Week 12

Study Arms (2)

Testosterone Cream

ACTIVE COMPARATOR

Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment

Drug: Testosterone Cream

Estring

ACTIVE COMPARATOR

Estring 2mg ring inserted vaginally once every 12 weeks

Drug: Estring

Interventions

Testosterone Cream DRUG

1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment

Also known as: intravaginal testosterone cream

Testosterone Cream

Estring DRUG

2mg ring inserted vaginally once every 12 weeks

Also known as: ESTRING Estrodial Vaginal Ring

Estring

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed Stage I-III breast cancer who are taking an aromatase inhibitor as adjuvant hormonal therapy. Patient must have started the aromatase inhibitor at least 60 days prior to enrolling.
• Postmenopausal estradiol levels at baseline as measured by standard laboratory analysis.
• Patient may be rendered postmenopausal through the use of a GnRH agonist, but must have confirmed post-menopausal levels of serum estradiol on two lab tests at least one month apart.
• If patient has been rendered post-menopausal by adjuvant chemotherapy but has had a period within the past 12 months, post-menopausal levels of serum estradiol must be documented on two lab tests at least 3 months apart.
• Age ≥18 and ≤80 years old.
• ECOG ≤1
• Adequate hematologic, hepatic, and renal function as defined by:
• Hgb ≥9 g/dL
• Absolute neutrophil count (ANC)/absolute granulocyte count (AGC) ≥1500 cells/mm3
• Platelet count ≥100,000/mm3
• Serum creatinine ≤1.5 mg/dL
• Total bilirubin ≤1.5 times the ULN; and aspartate aminotransferase ≤3 times the ULN
• Normal thyroid function tested within the past 6 months (Patients with a diagnosis of hypothyroidism and on thyroid supplementation must have had thyroid function tests in the normal range within the past 3 months)
• Patient must have recovered from the side effects of previous chemotherapy, surgery, or radiation therapy for early breast cancer.

You may not qualify if:

• History of radiation to the vaginal area
• Concurrent treatment with any type of oral, injectable or topical form of estrogen or androgen therapy including natural supplements marketed as hormone replacement products
• Initiation of topical moisturizers (for example, Replens), or herbal or alternative medicines to manage the symptoms of vaginal dryness while on study. Patients who were previously using these products may continue them with the same usage pattern while on study.
• Use of vaginal hormonal products (rings, inserts, creams, gels) containing estrogens or androgens within the past 30 days.
• History of an abnormal pap smear within the last 12 months
• History of endometrial or ovarian cancer
• Any episode of vaginal bleeding in the past 6 months that has not been evaluated by a gynecological exam and/or pelvic ultrasound
• History of sexual dysfunction prior to diagnosis of breast cancer ( Sexual dysfunction will be defined as loss of libido or inability to achieve orgasm for which patient sought medical attention or which patient felt significantly interfered with quality of life.)
• Moderate or severe depression for which the patient is receiving ongoing psychological counseling and/or taking antidepressants, and for whom, in the investigators opinion may be interfering in the patients sexual function independent of the side effects of breast cancer and aromatase inhibitor use.
• Use of any investigational agent for breast cancer within 3 weeks of study entry.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• Melisko ME, Goldman ME, Hwang J, De Luca A, Fang S, Esserman LJ, Chien AJ, Park JW, Rugo HS. Vaginal Testosterone Cream vs Estradiol Vaginal Ring for Vaginal Dryness or Decreased Libido in Women Receiving Aromatase Inhibitors for Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2017 Mar 1;3(3):313-319. doi: 10.1001/jamaoncol.2016.3904.

  PMID: 27832260 DERIVED

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Michelle Melisko, MD
• Organization: University of California, San Francisco

mmelisko@medicine.ucsf.edu

415-353-7070

Study Officials

• Michelle Melisko, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 16, 2008
• Study Start: March 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 2, 2014
• Results First Posted: June 2, 2014

Record last verified: 2014-05

Locations

US (1)