Trial record 6 of 15 for:    nichd Premature Ovarian Failure (POF)

Effects of an Estrogen Replacement Therapy Skin Patch on Ovulation in Women With Premature Ovarian Failure

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00370019
First received: August 29, 2006
Last updated: December 30, 2011
Last verified: December 2011
  Purpose

This study will determine whether giving estrogen replacement therapy through an estradiol patch can improve ovulation rates in women with spontaneous premature ovarian failure. The ovaries are glands in women that produce female hormones and normally release an egg once a month. In women with spontaneous premature ovarian failure, the ovaries stop working too soon. Women with this disorder have abnormally high levels of leuteinizing hormone (LH) in their blood, which impedes normal ovulation. In some women, estrogen replacement can suppress LH levels to the normal range.

Women between 18 and 40 years of age with premature ovarian failure may be eligible for this 4-month study. Participants receive either standard hormone replacement therapy, consisting of an estradiol patch and progestin tablets, or placebo. The placebo group receives patches and tablets that look the same as those for the group with active treatment but they contain no hormone. All participants wear the patch every day and take the tablets the first 12 days of each month. In addition to taking the study drug, participants have blood drawn once a week for the 16 weeks of the study.

At the end of the trial, women who were in the placebo group are offered the opportunity to receive the estrogen patch and progestin therapy for another 16 weeks and continue the blood tests to determine if they ovulate on this treatment.


Condition Intervention Phase
Premature Ovarian Failure
Drug: Estradiol/Medroxyprogesterone acetate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Effect of Transdermal Estradiol Replacement Therapy on Ovulation Rate in Women With Premature Ovarian Failure: A Randomized, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Serum progesterone in the ovulatory range.

Enrollment: 0
Study Start Date: August 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Estradiol/Medroxyprogesterone acetate
    N/A
Detailed Description:

Premature ovarian failure (POF) is a life altering and distressing diagnosis for women due to associated infertility. Despite having amenorrhea and markedly elevated serum gonadotropin levels, approximately 50% of women with 46XX spontaneous premature ovarian failure have ovarian follicles that function intermittently. These follicles are faced with high serum LH levels. Normally, women have their LH levels in the range of 3-14 u/L except in the preovulatory stage, when it rises above 20 u/L. At that level it works on LH receptors on the granulosa cells and transforms the follicle in the corpus leutium. In POF, continuous high level of LH prematurely lutienizes growing follicles and thereby causes follicle dysfunction. We have shown by histological examination that inappropriate luteinization is a major mechanism of Graffian follicle dysfunction in these women.

We have found that approximately 50% women with premature ovarian failure have LH levels in the normal range while they are taking 100 mcg per day of our standardized transdermal estradiol therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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, or in the menopausal range, at least one month apart, and a normal 46, XX karyotype, diagnosed with premature ovarian failure prior to the age of 40 who are between the age of 18 and 40 years will be candidates.

Patients will be screened under the protocol 91-CH-0127 (Ovarian follicle function in patients with karyotypically normal spontaneous premature ovarian failure).

EXCLUSION CRITERIA:

  1. General smokers (greater than 2 cigarettes/d), alcohol users (greater than 2 drinks/d), body mass index (BMI, kg/m(2) greater than or equal to 30 and less than or equal to 19, major dermatologic disorders, or a history of skin sensitivity to adhesive bandages, tape or transdermal matrix patches
  2. Hysterectomy
  3. Medication use current and/or past use of: diuretics, anticoagulants (heparin, coumadin), glucocorticoid drugs, gonadotropin-releasing hormone agonist or antagonist therapy, chemotherapy, use of other therapies to induce ovulation such as clomiphene citrate and other assisted reproductive technologies.(At present there are no proven ways to improve ovulation rate in these women)
  4. Medical history of anorexia nervosa, hyperprolactinemia, Cushing's syndrome, gastrectomy, osteogenesis imperfecta, mastocytosis, rheumatoid arthritis, long term parenteral nutrition, hemolytic anemia, hemochromatosis and thalassemia, ankylosing spondylitis, multiple myeloma, any cancer, any other major illness
  5. Contraindications to hormone replacement therapy thromboembolic event associated with previous estrogen use history of endometrial cancer or hyperplasia history of breast cancer

hypertriglyceridemia (fasting triglyceride levels greater than 250 mg/dL) undiagnosed vaginal bleeding known sensitivity to agents.

Active liver disease with more than 3 times elevation of liver enzymes.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370019

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Responsible Party: Lawrence M. Nelson, M.D./National Institute of Child Health and Human Development, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00370019     History of Changes
Other Study ID Numbers: 060201, 06-CH-0201
Study First Received: August 29, 2006
Last Updated: December 30, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Premature Ovarian Failure
Ovulation
Fertility
Estrogen Replacement
Follicle Function
Premature Menopause
POF

Additional relevant MeSH terms:
Menopause, Premature
Primary Ovarian Insufficiency
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Medroxyprogesterone
Medroxyprogesterone Acetate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014