Hormone Replacement in Young Women With Premature Ovarian Failure

NCT00001951 | Completed Phase 2

• 2 other identifiers: 00004500-CH-0045
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The human ovary produces male sex hormones (androgen) and female sex hormones (estrogen). Currently, androgen is not included in hormone replacement therapy for women with premature ovarian failure. Present hormone replacement therapy (HRT) was designed to treat women who experience ovarian failure at menopause (around the age of 50). However, 1% of women will experience premature failure of the ovaries before the age of 40. There have been no studies conducted to determine proper hormone replacement therapies for these younger women. Some research suggests that the usual menopausal hormone replacement therapy is not adequate to protect young women with premature ovarian failure from developing osteoporosis. Women with premature ovarian failure have abnormally low levels of androgens circulating in their blood. This may contribute to the increase risk for osteoporosis. This study will compare two treatment plans for women with premature ovarian failure. Treatment plan one will be physiological estrogen hormone replacement. Treatment plan two will be physiological estrogen hormone replacement plus androgen. The study will attempt to determine which plan is more beneficial to women in relation to osteoporosis and heart disease. The hormones will be contained in patches and given by placing the patches against the patient's skin. The patches were designed to deliver the same amount of hormone as would be normally produced by the ovary in young women. The success of the treatment will be measured by periodically checking the density of patient's bone in the leg (femoral neck bone) . Researchers will take an initial (baseline) measurement of bone density before beginning treatment and then once a year, for 3 additional years, during treatment. The study will also consider bone density of the spine, bone turnover, heart disease risk factors, and psychological state.

Conditions

Healthy; Osteoporosis; Premature Ovarian Failure

Keywords

Bone; Cognition; Estrogen; Mood; Testosterone; Osteoporosis; Ovarian Failure; Hormone Replacement Therapy; POF; Premature Ovarian Failure

Interventions

TMTDS DRUG

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with karyotypically normal spontaneous premature ovarian failure (as defined by screening protocol 91-CH-0127, i.e. women who have at least 4 months of amenorrhea, two FSH levels above 40 mIU/ml, at least one month apart, and a normal 46, XX karotype, diagnosed with premature ovarian failure prior to the age of 40) who are between the age of 18 and 42 years will be candidates.

You may not qualify if:

• General:
• Smokers (more than 2 cigarettes per day).
• Alcohol users (more than 2 drinks of alcohol per day).
• Body mass index (BMI, kg/m(2)) greater than or equal to 30 and less than or equal to 19.
• Previous history of hip fracture or other active hip pathology.
• Abnormalities of the hip precluding the assessment of bone mineral density.
• Major dermatologic disorders, or a history of skin sensitivity to adhesive bandages, tape or transdermal matrix patches.
• Hirsutism score greater than 8.
• Acne score greater than 1.
• Hysterectomy
• Baseline free testosterone (FT) levels above the normal range (greater than 6.3 pg/ml in our current essay) and/or SHBG levels less than 36 nmol/L.
• Medical use:
• Any prior treatment in the past 6 months known to affect bone other than estrogen (i.e., calcitonin, biphosphonates, fluoride, anabolic steroids, testosterone, or herbal therapy that contains androstenedione, and DHEA).
• Current and/or past use of: diuretics, anticoagulants (heparin, Coumadin), glucocorticoid drugs, gonadotropin-releasing hormone agonist or antagonist therapy, chemotherapy.
• Medical history of:

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Kalantaridou SN, Davis SR, Nelson LM. Premature ovarian failure. Endocrinol Metab Clin North Am. 1998 Dec;27(4):989-1006. doi: 10.1016/s0889-8529(05)70051-7.

  PMID: 9922918 BACKGROUND

• Popat VB, Calis KA, Kalantaridou SN, Vanderhoof VH, Koziol D, Troendle JF, Reynolds JC, Nelson LM. Bone mineral density in young women with primary ovarian insufficiency: results of a three-year randomized controlled trial of physiological transdermal estradiol and testosterone replacement. J Clin Endocrinol Metab. 2014 Sep;99(9):3418-26. doi: 10.1210/jc.2013-4145. Epub 2014 Jun 6.

  PMID: 24905063 DERIVED

• Guerrieri GM, Martinez PE, Klug SP, Haq NA, Vanderhoof VH, Koziol DE, Popat VB, Kalantaridou SN, Calis KA, Rubinow DR, Schmidt PJ, Nelson LM. Effects of physiologic testosterone therapy on quality of life, self-esteem, and mood in women with primary ovarian insufficiency. Menopause. 2014 Sep;21(9):952-61. doi: 10.1097/GME.0000000000000195.

  PMID: 24473536 DERIVED

MeSH Terms

Conditions

Osteoporosis; Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: January 19, 2000
• Study Start: December 1, 1999
• Study Completion: October 1, 2006
• Last Updated: February 27, 2007

Record last verified: 2006-10

Locations

US (1)