A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.

What Was Tested

This registered phase 2 trial tested Leuprolide.

It had two arms (groups): Leuprorelin (GF) (experimental) and Leuprorelin (GC) (experimental).

The registry classes the interventions as drug.

More on the Plan

Gonadotropin-releasing hormone, also called luteinizing hormone releasing hormone, is a neuropeptide hormone released from the hypothalamus.

Gonadotropin-releasing hormone binds to specific gonadotropin-releasing hormone receptors in the cell membrane of pituitary gland cells, inducing the cells to produce and release the gonadotropins: luteinizing hormone and follicle-stimulating hormone.

Luteinizing hormone and follicle-stimulating hormone are released into the general circulation and stimulate the gonads to produce and release the sex steroids: testosterone and estrogen.

Follicle-stimulating hormone also controls gametogenesis.

Who Took Part

The registry lists 80 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Female patients with measurable uterine fibroids confirmed by vaginal or abdominal ultrasound, deemed otherwise healthy. A body mass index in the range 18 to 28. Oestradiol, progesterone, luteinizing hormone and follicle stimulating hormone results within the range of normal ovarian function. Regular menstruation (except for symptoms of fibroids). Females of childbearing potential who are sexually active must agree to use barrier contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: acute pelvioperitonitis, ovarian cysts, persistent corpus luteum; history of bilateral oophorectomy, hysterectomy, or hypophysectomy; impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2006-06 with completion listed for 2007-07.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of measured E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL (time frame: Weeks 5 through Final Visit).

It also tracked 3 secondary outcomes, for example Time course of E2 (17β-estradiol) Serum Concentration levels, Time course of E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL and Rate of E2 (17β-estradiol) Serum Concentration levels less than or equal to 50, 40 and 30 ng/dL.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.