Hormone Replacement for Premature Ovarian Insufficiency

NCT02922348 | Withdrawn Phase 3 DMC

• 1 other identifier: 823553
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Ovarian Insufficiency

Keywords

premature ovarian failure; hormone replacement

Outcome Measures

Primary Outcomes (1)

• Recruitment

  Patient willingness to participate and be randomized

  1 year

Secondary Outcomes (27)

• Vasomotor symptoms - Greene Climacteric Scale

  1 year

• Vasomotor symptoms - Menopausal Vasomotor Symptoms (MVS) survey

  1 year

• Bleeding profile - Bleeding questionnaire

  1 year

• Bleeding profile - Menstrual diary

  1 year

• Sexual dysfunction - Female Sexual Function Index (FSFI)

  1 year

Study Arms (2)

Hormone Replacement Therapy

EXPERIMENTAL

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

Combined Oral Contraceptives

EXPERIMENTAL

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

Interventions

Hormone Replacement Therapy DRUG

Hormone replacement therapy as indicated in Arm 1

Also known as: Estradiol, Prometrium, Micronized progestin, Medroxyprogesterone, Climera, Provera

Hormone Replacement Therapy

Combined Oral Contraceptives DRUG

Combined oral contraceptives as indicated in Arm 2

Also known as: Ethinyl estradiol, Norgestimate

Combined Oral Contraceptives

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Fertility Care

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Hormone Replacement Therapy; Estradiol; Progesterone; Medroxyprogesterone; Medroxyprogesterone Acetate; Contraceptives, Oral, Combined; Ethinyl Estradiol; norgestimate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners; Hydroxyprogesterones; Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norpregnatrienes; Norpregnanes; Norsteroids; Estrogenic Steroids, Alkylated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: October 4, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)