CompletedPhase 3

LutrePulse Hypogonadotropic Hypogonadism

United States, Canada39 participantsStarted 2014-04-01

Plain-language summary

To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the OmniPod pump versus placebo

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women 18-40 years old * Body mass index (BMI) between 18 and 38 kg/m2 * Clinical history or recently diagnosed with primary amenorrhea with hypogonadotropic hypogonadism * Hormonal values in a centrally analyzed fasting blood sample: FSH \<5 IU/L and mean LH \<5 IU/L * Desire to become pregnant * Discontinued estrogen-progesterone replacement therapy at least 1 month before screening * Negative progestin challenge test performed during screening * PAP smear within 24 months of the initial visit * Normal or stable CT scan or MRI scan of the hypothalamic pituitary region * Prolactin and thyroid-stimulating hormone (TSH) within normal clinical laboratory limits * Male partner with normal semen analysis, including volume, liquefaction time, sperm count, and motility, according to the local laboratory normal criteria, within the past year * Normal transvaginal ultrasound at screening with respect to uterus and adnexa (presence of both ovaries and tubes, without evidence of clinically significant abnormality) and with normal uterine cavity and normal cervix * Tube patency on saline tubal perfusion, hysterosalpingography or laparoscopy on file within the past 2 years Exclusion Criteria: * Any medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the drug * A history of, or currently diagnosed with clinically important cardiovascular, pulmonary (e.g. serious corticosteroid-dependent asthma), gastrointestinal, hepa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ovulation Rate

Timeframe: From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks

Trial details

NCT IDNCT01976728

SponsorFerring Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02-23

Results submitted2021-01-08

View on ClinicalTrials.gov More Primary Amenorrhea With Hypogonadotropic Hypogonadism trials