Abstract
Vaginal ring delivery of selective progesterone receptor modulators (SPRMs) is under
development to address the limitations of current hormonal methods that affect use
and effectiveness. This method would be appropriate for use in women with contraindications
to, or preferences to avoid, estrogens. A contraceptive vaginal ring (CVR) also eliminates
the need for daily dosing and therefore might improve the effectiveness of contraception.
The principal contraceptive effect of SPRMs is the suppression of ovulation. One limiting
factor of chronic SPRM administration is the development of benign endometrial thickening
characterized as PRM-associated endometrial changes. Ulipristal acetate (UPA) is approved
for use as an emergency contraceptive pill, but no SPRM is approved for regular contraception.
The Population Council is developing an ulipristal acetate CVR for regular contraception.
The CVR studied is of a matrix design composed of micronized UPA mixed in a silicone
rubber matrix The target product is a ring designed for continuous use over 3 months
delivering near steady-state drug levels that will suppress ovulation. Results from
Phase 1 and 2 studies demonstrate that suppression of ovulation occurs with UPA levels
above 6–7 ng/mL.
Keywords
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Article info
Publication history
Published online: October 08, 2012
Accepted:
August 28,
2012
Received:
July 8,
2012
Identification
Copyright
© 2013 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
