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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02922348
Other study ID # 823553
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date March 1, 2016
Est. completion date December 1, 2018

Study information

Verified date July 2019
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 1, 2018
Est. primary completion date December 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 45 Years
Eligibility 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

Study Design


Intervention

Drug:
Hormone Replacement Therapy
Hormone replacement therapy as indicated in Arm 1
Combined Oral Contraceptives
Combined oral contraceptives as indicated in Arm 2

Locations

Country Name City State
United States Penn Fertility Care Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment Patient willingness to participate and be randomized 1 year
Secondary Vasomotor symptoms - Greene Climacteric Scale Greene Climacteric Scale 1 year
Secondary Vasomotor symptoms - Menopausal Vasomotor Symptoms (MVS) survey Menopausal Vasomotor Symptoms (MVS) survey 1 year
Secondary Bleeding profile - Bleeding questionnaire Bleeding questionnaire 1 year
Secondary Bleeding profile - Menstrual diary Menstrual diary 1 year
Secondary Sexual dysfunction - Female Sexual Function Index (FSFI) Female Sexual Function Index (FSFI) 1 year
Secondary Satisfaction as Contraceptive Method Birth Control Satisfaction Assessment 1 year
Secondary Hormone Assays - FSH (mIU/mL) FSH (mIU/mL) 1 year
Secondary Hormone Assays - Estradiol (pg/mL) Estradiol (pg/mL) 1 year
Secondary Hormone Assays - Sex-hormone binding globulin (nmol/L) Sex-hormone binding globulin (nmol/L) 1 year
Secondary Hormone Assays - Total testosterone (ng/dL) Total testosterone (ng/dL) 1 year
Secondary Hormone Assays - Free testosterone (ng/dL) Free testosterone (ng/dL) 1 year
Secondary Hormone Assays - Anti-mullerian hormone (pmol/l) Anti-mullerian hormone (pmol/l) 1 year
Secondary Hormone Assays - Dehydroepiandrosterone Sulfate (ng/mL) Dehydroepiandrosterone Sulfate (ng/mL) 1 year
Secondary Hormone Assays - Thyroid stimulating hormone (U/mL) Thyroid stimulating hormone (U/mL) 1 year
Secondary Bone Turnover Markers - Serum osteocalcin (ng/mL) Serum osteocalcin (ng/mL) 1 year
Secondary Bone Turnover Markers - Serum N-telopeptide of type I collagen (nmol/L) Serum N-telopeptide of type I collagen (nmol/L) 1 year
Secondary Cardiovascular Risk Markers - Total cholesterol Total cholesterol (mg/dL) 1 year
Secondary Cardiovascular Risk Markers - Triglycerides (mg/dL) Triglycerides (mg/dL) 1 year
Secondary Cardiovascular Risk Markers - Lipoprotein a (mg/dL) Lipoprotein a (mg/dL) 1 year
Secondary Cardiovascular Risk Markers - Fasting glucose (mg/dL) Fasting glucose (mg/dL) 1 year
Secondary Cardiovascular Risk Markers - Fasting insulin (pmol/L) Fasting insulin (pmol/L) 1 year
Secondary Cardiovascular Risk Markers - Homeostatic model assessment (HOMA) insulin Homeostatic model assessment (HOMA) insulin 1 year
Secondary Cardiovascular Risk Markers - Tissue-type plasminogen activator antigen (ng/mL) Tissue-type plasminogen activator antigen (ng/mL) 1 year
Secondary Cardiovascular Risk Markers - Plasma plasminogen activator inhibitor 1 (ng/mL) Plasma plasminogen activator inhibitor 1 (ng/mL) 1 year
Secondary Cardiovascular Risk Markers - Fibrinogen (mg/dL) Fibrinogen (mg/dL) 1 year
Secondary Cardiovascular Risk Markers - Factor VII (%) Factor VII (%) 1 year
Secondary Cardiovascular Risk Markers - C-reactive protein (mg/L) C-reactive protein (mg/L) 1 year
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