Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 6 for:    "Sex Development Disorder" | "Contraceptive Agents, Male"
Previous Study | Return to List | Next Study

Hormone Replacement for Premature Ovarian Insufficiency (HOPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922348
Recruitment Status : Withdrawn
First Posted : October 4, 2016
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The investigators intend to establish feasibility/acceptability of a pilot randomized trial comparing hormone replacement therapy (HRT) and combined oral contraceptives (COCs) in women with premature ovarian insufficiency to estimate differences in quality of life (QOL) and serum hormone assays and markers of bone turnover/cardiovascular risk. At baseline, QOL survey will be administered and serum testing performed. Patients then randomized to HRT or COCs. Repeat testing will be performed after 3 and 6 months.

Condition or disease Intervention/treatment Phase
Primary Ovarian Insufficiency Drug: Hormone Replacement Therapy Drug: Combined Oral Contraceptives Phase 3

Detailed Description:
Premature ovarian insufficiency (POI) is a term used to describe when a woman's ovaries stop working normally before the natural age of menopause. Early sequelae of POI include vasomotor symptoms, vaginal dryness, mood swings and insomnia due to estrogen deficiency. Long-term sequelae such as loss of bone mineral density and cardiovascular risk carry are considerable concerns. While exogenous estrogen replacement is recommended for the POI patient population, the optimal regimen for replacement is not clear. One approach to hormone replacement therapy (HRT) is to mimic physiologic ovarian function through full replacement doses of estrogen (either orally or transdermally) to reach the typical serum estradiol levels of a menstruating woman (approximately 104 pg/mL per day) with cyclic progestin therapy for endometrial protection. Another approach uses daily combined estrogen-progestin oral contraceptives (COCs), for ease of administration and increased social acceptability. To date, few studies have been performed comparing the two treatment methods in terms of quality of life measures (vasomotor symptoms, bleeding profile, sexual dysfunction, satisfaction with contraception), endocrine function, bone turnover or cardiovascular risk in POI patients. In this proposal, the investigators intend to establish feasibility and acceptability of a pilot randomized controlled trial comparing traditional HRT with COCs in women with POI and to evaluate differences in quality of life measures, hormone assays, bone turnover and cardiovascular risk between treatment arms. The investigators hypothesize that acceptability and feasibility of the pilot trial will be high and that differences will be detected for all measured variables between treatment arms. Demonstration of feasibility and acceptability of this pilot would allow for the pursuit of a larger trial and identification of a superior treatment regimen would have a meaningful impact on the short and long-term care of this patient population.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Hormone Replacement for Women With Premature Ovarian Insufficiency
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018


Arm Intervention/treatment
Experimental: Hormone Replacement Therapy
Patient will be given hormones in the form of: transdermal estradiol patch (Climara) 100 mcg/24 hours weekly, progesterone (Prometrium) 200 mg per day for first 12 calendar days of each month (If patients insurance plan does not cover transdermal estradiol, they will be prescribed oral estradiol 2 mg daily. If patients insurance plan does not cover Prometrium, they will be prescribed medroxyprogesterone (Provera) 10 mg per day for first 12 calendar days of each month).
Drug: Hormone Replacement Therapy
Hormone replacement therapy as indicated in Arm 1
Other Names:
  • Estradiol
  • Prometrium
  • Micronized progestin
  • Medroxyprogesterone
  • Climera
  • Provera

Experimental: Combined Oral Contraceptives
Patients will be given hormones in the form of: monophasic combined oral contraceptive containing ethinyl estradiol 0.035 mg and norgestimate 0.25 mg, 1 tablet daily (21 days of active pills and 7 days of inactive pills)
Drug: Combined Oral Contraceptives
Combined oral contraceptives as indicated in Arm 2
Other Names:
  • Ethinyl estradiol
  • Norgestimate




Primary Outcome Measures :
  1. Recruitment [ Time Frame: 1 year ]
    Patient willingness to participate and be randomized


Secondary Outcome Measures :
  1. Vasomotor symptoms - Greene Climacteric Scale [ Time Frame: 1 year ]
    Greene Climacteric Scale

  2. Vasomotor symptoms - Menopausal Vasomotor Symptoms (MVS) survey [ Time Frame: 1 year ]
    Menopausal Vasomotor Symptoms (MVS) survey

  3. Bleeding profile - Bleeding questionnaire [ Time Frame: 1 year ]
    Bleeding questionnaire

  4. Bleeding profile - Menstrual diary [ Time Frame: 1 year ]
    Menstrual diary

  5. Sexual dysfunction - Female Sexual Function Index (FSFI) [ Time Frame: 1 year ]
    Female Sexual Function Index (FSFI)

  6. Satisfaction as Contraceptive Method [ Time Frame: 1 year ]
    Birth Control Satisfaction Assessment

  7. Hormone Assays - FSH (mIU/mL) [ Time Frame: 1 year ]
    FSH (mIU/mL)

  8. Hormone Assays - Estradiol (pg/mL) [ Time Frame: 1 year ]
    Estradiol (pg/mL)

  9. Hormone Assays - Sex-hormone binding globulin (nmol/L) [ Time Frame: 1 year ]
    Sex-hormone binding globulin (nmol/L)

  10. Hormone Assays - Total testosterone (ng/dL) [ Time Frame: 1 year ]
    Total testosterone (ng/dL)

  11. Hormone Assays - Free testosterone (ng/dL) [ Time Frame: 1 year ]
    Free testosterone (ng/dL)

  12. Hormone Assays - Anti-mullerian hormone (pmol/l) [ Time Frame: 1 year ]
    Anti-mullerian hormone (pmol/l)

  13. Hormone Assays - Dehydroepiandrosterone Sulfate (ng/mL) [ Time Frame: 1 year ]
    Dehydroepiandrosterone Sulfate (ng/mL)

  14. Hormone Assays - Thyroid stimulating hormone (U/mL) [ Time Frame: 1 year ]
    Thyroid stimulating hormone (U/mL)

  15. Bone Turnover Markers - Serum osteocalcin (ng/mL) [ Time Frame: 1 year ]
    Serum osteocalcin (ng/mL)

  16. Bone Turnover Markers - Serum N-telopeptide of type I collagen (nmol/L) [ Time Frame: 1 year ]
    Serum N-telopeptide of type I collagen (nmol/L)

  17. Cardiovascular Risk Markers - Total cholesterol [ Time Frame: 1 year ]
    Total cholesterol (mg/dL)

  18. Cardiovascular Risk Markers - Triglycerides (mg/dL) [ Time Frame: 1 year ]
    Triglycerides (mg/dL)

  19. Cardiovascular Risk Markers - Lipoprotein a (mg/dL) [ Time Frame: 1 year ]
    Lipoprotein a (mg/dL)

  20. Cardiovascular Risk Markers - Fasting glucose (mg/dL) [ Time Frame: 1 year ]
    Fasting glucose (mg/dL)

  21. Cardiovascular Risk Markers - Fasting insulin (pmol/L) [ Time Frame: 1 year ]
    Fasting insulin (pmol/L)

  22. Cardiovascular Risk Markers - Homeostatic model assessment (HOMA) insulin [ Time Frame: 1 year ]
    Homeostatic model assessment (HOMA) insulin

  23. Cardiovascular Risk Markers - Tissue-type plasminogen activator antigen (ng/mL) [ Time Frame: 1 year ]
    Tissue-type plasminogen activator antigen (ng/mL)

  24. Cardiovascular Risk Markers - Plasma plasminogen activator inhibitor 1 (ng/mL) [ Time Frame: 1 year ]
    Plasma plasminogen activator inhibitor 1 (ng/mL)

  25. Cardiovascular Risk Markers - Fibrinogen (mg/dL) [ Time Frame: 1 year ]
    Fibrinogen (mg/dL)

  26. Cardiovascular Risk Markers - Factor VII (%) [ Time Frame: 1 year ]
    Factor VII (%)

  27. Cardiovascular Risk Markers - C-reactive protein (mg/L) [ Time Frame: 1 year ]
    C-reactive protein (mg/L)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female patients,
  • Between 14-45 years of age
  • Post-menarchal
  • Presence of uterus
  • POI as defined by: change in menstrual function (oligomenorrhea and/or amenorrhea), elevated serum serum follicle stimulating hormone (FSH), low serum estradiol concentrations, or estrogen deficiency symptoms.

Exclusion Criteria:

  • Pregnancy or lactation within previous 3 months
  • Use of hormonal contraception or replacement within previous 3 months
  • Any contraindication to oral contraceptive pills or hormone replacement therapy per the current drug labels. These could include, but are not limited to: history of venous thromboembolism,estrogen-sensitive cancer history, regular cigarette smoking and history of or active liver disease, etc.
  • Patients will be screened for pregnancy with a urine HCG test at time of screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922348


Locations
Layout table for location information
United States, Pennsylvania
Penn Fertility Care
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania

Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02922348     History of Changes
Other Study ID Numbers: 823553
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Pennsylvania:
premature ovarian failure
hormone replacement
Additional relevant MeSH terms:
Layout table for MeSH terms
Disorders of Sex Development
Sex Chromosome Disorders of Sex Development
Contraceptive Agents, Male
Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Urogenital Abnormalities
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Medroxyprogesterone Acetate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents
Medroxyprogesterone