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Articles

Is there a lactose-free hormone replacement therapy (HRT)?

24 February 2020This Medicines Q&A provides a summary of the currently available HRT preparations that contain lactose and suggests options for lactose-free alternatives.
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Lactation Safety Information

Pessaries / Injection

Pessaries / Injection
Yes
Limited published evidence of safety
Minimal absorption from the infant's GI tract
Theoretical risk of interference with early lactation
24 September 2020

New Medicines

MilprosaIn vitro fertilisation; weekly vaginal ring for luteal supplementation in IVF

Information

Milprosa
New formulation
Not Known
Teva

Development and Regulatory status

None
None
Approved (Licensed)
Oct 20Ferring Pharmaceuticals acquired global rights to progesterone vaginal ring from Teva [5].
Apr 20US FDA approves progesterone vaginal ring (Milprosa) to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment programme for infertile women [11].
Mar 18Still listed as pre-registration on company website [7].
Dec 15A licence application has been filed, but which authority not stated; assume US [4].
Oct 15According to the Teva 2014 annual report, no further development or commercialisation is planned [5].
Oct 15Teva filed an NDA with the US FDA in 2010 and received a complete response letter in 2011, requiring Teva to conduct a safety/efficacy study in women aged over 34 years prior to approval or as a post-marketing commitment. Teva intended file a complete response to this letter in 2014 [5].

Category

Transvaginal ring designed to continuously release a steady dose of progesterone
One in six couples in the UK is affected by infertility & a small proportion need treatment with assisted conception. The average success (ie live birth) rates for IVF treatment is now just under 25% [2].
In vitro fertilisation; weekly vaginal ring for luteal supplementation in IVF
Vaginal

Trial or other data

Jan 21No further development reported [4].
Jul 19Ferring pharmaceuticals complete a PIII trial (NCT03565211) assessing the safety of Progesterone Vaginal Ring (PVR) in women undergoing fresh embryo transfer (ART). The trial was initiated in July 2018 and enrolled 352 patients in the US [10].
Jul 18PIII SARA trial to to assess the safety of Progesterone Vaginal Ring (PVR) in women undergoing fresh embryo transfer (ART) starts (NCT03565211). 240 patients will be recruited in the US. Collection of primary outcome data (Cumulative rate of spontaneous abortions occurring on or before 12 weeks post-oocyte retrieval) is due to complete Mar 19 [9].
Jul 18Ferring Pharmaceuticals plans a PIII trial for female infertility in the US (NCT03565211) [8].
Apr 13Sub-analysis of PIII trial (n=1297) comparing efficacy and safety of once-weekly Milprosa presented at 61st Annual Meeting of Pacific Coast Reproductive Society. At 8 weeks gestation, the overall multiple pregnancy rates were 41.3% with Milprosa vs. 39.7% with 8% progesterone vaginal gel. At 12 weeks gestation, the overall multiple pregnancy rates were 39.3% and 37.8% for Milprosa and the vaginal gel, respectively. The overall multiple live birth rates were 38.7% with Milprosa and 36.2% with vaginal gel. The mean number of embryos transferred was 2.13 for both groups. [3]
Oct 12Results of a PIII randomized, single-blind trial of Milprosa reported at the American Society for Reproductive Medicine. The trial found similar pregnancy rates in women treated with Milprosa vs daily 8% progesterone gel for luteal supplementation in women undergoing embryo transfer during IVF at days 3 and 5. A patient satisfaction survey assessed all 1,297 women in the trial; 262 women had used at least one progesterone treatment (injection, oral/vaginal capsule, gel) in a previous IVF cycle prior to entering this study. Women on Milprosa more frequently reported the method to be more convenient, less messy, less stressful and causing less leakage [1].