Ovarian function during and after treatment with the new progestagen Org 30659

Area of Science:

• Reproductive endocrinology
• Pharmacology of steroid hormones

Background:

• Selective progestagenic steroids are key in hormonal therapies.
• Understanding the ovarian effects of novel compounds like Org 30659 is crucial for developing new contraceptives or treatments.

Purpose of the Study:

• To assess the impact of varying oral doses of Org 30659 on ovarian function over 21 days.
• To determine the dose-response relationship and reversibility of Org 30659's effects on ovulation.

Main Methods:

• A randomized, double-blind, dose-finding study involving 81 healthy women aged 19-40.
• Participants received daily oral doses of Org 30659 (0.060-0.240 mg) or desogestrel (0.075 mg) for 21 days.
• Ovarian activity was monitored via follicular diameter and hormone levels (estradiol, progesterone, FSH, LH).

Main Results:

• Org 30659 demonstrated dose-dependent suppression of ovarian activity, with no ovulation observed in any treatment group.
• Ovulation resumed on average 16.5 to 22.1 days post-treatment, indicating reversibility.
• All tested doses of Org 30659 were well-tolerated, with minimal side effects and low discontinuation rates.

Conclusions:

• Oral administration of Org 30659 (0.060-0.240 mg/day) effectively suppresses ovarian function and inhibits ovulation.
• The observed ovarian suppression is dose-dependent and readily reversible upon cessation of treatment.
• Org 30659 is a safe and effective option for oral administration over 21 days in healthy female volunteers.