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Articles

Safety in Lactation: Combined hormonal contraceptives

27 October 2020Combined hormonal contraceptives (CHC) are a combination of an oestrogen and progestogen administered either orally, transdermally or vaginally (via a vaginal ring). The oestrogen component…

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

As a contraceptive when combined with a progestogen

As a contraceptive when combined with a progestogen
Progestogen-only contraceptive
Avoid in infants aged up to 6 weeks. Use with caution in infants aged over 6 weeks - a progestogen-only contraceptive preferred during lactation at any stage – see summary
24 September 2020

New Medicines

Imvexxy Vulvovaginal or vaginal atrophy-associated moderate-to-severe vaginal pain during sexual intercourse (dyspareunia) in postmenopausal women - vaginal formulation [2].

Information

Imvexxy
New formulation VagiCap™ softgel capsule
Theramex
TherapeuticsMD

Development and Regulatory status

None
None
Launched
Dec 21Therapeutics MD annual report suggests plans to commercialise Imvexxy outside US, but development plans in UK currently unclear [6].
Jun 19TherapeuticsMD enters into a exclusive license and supply agreement with Theramex to commercialise Imvexxy outside of the US, excluding Canada and Israel, for which TherapeuticsMD has licensed Imvexxy to Knight Therapeutics [5].
Sep 18Launched in the US [5].
May 18FDA approval of Imvexxy (estradiol vaginal inserts 4mcg and 10mcg) for the treatment of moderate-to-severe dyspareunia, is based on the results from the PIII REJOICE trial [5].
May 18Approved in US [4].
Dec 17Therapeutics MD resubmitted the New Drug Application (NDA) to the US FDA for Yuvvexy (applicator-free estradiol vaginal softgel capsule) for moderate-to-severe dyspareunia due to menopause.[4]
Nov 17The FDA have now agreed to waive the preapproval safety study, as long as the company agrees to postapproval observational study to monitor safety. TherapeuticsMD plan to resubmit for filing with the FDA in 2017.[3]
Sep 17TherapeuticsMD submitted additional endometrial long-term safety information to support its NDA for estradiol vaginal.[2,3]
May 17TherapeuticsMD receives complete response letter from US FDA in which 12-month safety data (rather than the 12 weeks worth of data submitted) were requested. The main point of concern for the FDA was endometrial safety. [2,3]
Feb 17TherapeuticsMD has patents pending for Estradiol vaginal in Europe.[2]
Sep 16Accepted for review by US FDA. [2]
Jul 16Filed for approval to US FDA. [2,3]

Category

Oestrogen receptor antagonist formulated as low dose estradiol VagiCap™ softgel capsule
80% of women experience menopausal symptoms and 45% find it distressing. Symptoms include hot flushes, night sweats, increase in weight and vaginal atrophy. Vaginal atrophy occurs because of reduced endogenous oestrogen production, leading to the vaginal walls to become thin and dry. This may lead to itchiness, discomfort, pain during intercourse, vaginal discharge, and urinary problems. About 30% of women experience vaginal symptoms in the early postmenopausal period and 47% post menopause [1].
Vulvovaginal or vaginal atrophy-associated moderate-to-severe vaginal pain during sexual intercourse (dyspareunia) in postmenopausal women - vaginal formulation [2].
Vaginal

Trial or other data

Oct 15PIII REJOICE Trial (NCT02253173) completed. The 12-week, randomised, double-blind, placebo-controlled trial evaluated safety and efficacy of estradiol vaginal (25µg, 10µg and 4µg), in 764 pts with symptoms of vulval vaginal atrophy (VVA) (including dyspareunia), due to menopause. All doses demonstrated significant change from baseline in the % of vaginal superficial cells, % of vaginal parabasal cells, vaginal pH and self-reported severity of dyspareunia. Vaginal dryness was reduced by all doses at weeks 2, 6, 8 and 12. For all the three doses, statistical improvement vs. placebo was seen at week 2 through week 12. After 12 weeks, FSFI scores increased signficantly at the 10mcg and 25mcg doses vs. placebo. The results demonstrated negligible to very low systemic absorption of estradiol vaginal. Estradiol vaginal was well tolerated. Adverse events were headache, vaginal discharge, nasopharyngitis and vulvovaginal pruritus. No drug-related serious adverse events were reported [2].