Use of a levonorgestrel-containing intrauterine system with supplemental estrogen improves symptoms in perimenopausal women

Santoro, Nanette; Teal, Stephanie; Gavito, Christina; Cano, Sandra; Chosich, Justin; Sheeder, Jeanelle

doi:10.1097/gme.0000000000000557

Cited by 32 publications

(26 citation statements)

References 27 publications

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“…The use of oral or percutaneous estrogen therapy (ET) together with LNG-IUS is not only effective for alleviating the symptoms of menopause but also for preventing endometrial hyperplasia. Even in the case of a normal menstrual cycle, if the symptoms of menopause are severe, the use of a combination therapy of low-dose percutaneous estrogen and LNG-IUS could effectively control a hot flush [8]. In addition, some reports have shown that it could help improve symptoms that appear during menopausal transition such as depression, reduced quality of sleep, and increased anxiety [9,10].…”

Section: Mht For Women In Menopausal Transitionmentioning

confidence: 99%

The 2020 Menopausal Hormone Therapy Guidelines

Lee

Cho

et al. 2020

J Menopausal Med

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Section: Mht For Women In Menopausal Transitionmentioning

confidence: 99%

The 2020 Menopausal Hormone Therapy Guidelines

Lee

Cho

et al. 2020

J Menopausal Med

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“…Women with perimenopausal complaints, using LNG-IUS, can start estrogen therapy as the LNG-IUS will protect the endometrium. 88 …”

Section: Discussionmentioning

confidence: 99%

Femilis® 60 Levonorgestrel-Releasing Intrauterine System–-A Review of 10 Years of Clinical Experience

Wildemeersch

Andrade

Goldstuck

2016

Clin Med�Insights�Reprod�Health

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OBJECTIVEThe aim of this study was to update the clinical experience with the Femilis® 60 levonorgestrel-releasing intrauterine system (LNG-IUS), now up to 10 years in parous and nulliparous women, particularly with regard to ease and safety of insertion, contraceptive performance, retention, acceptability, continuation of use, impact on menstrual blood loss (MBL), and duration of action.STUDY DESIGNUsing the Femilis® 60 LNG-IUS releasing 20 µg of levonorgestrel/day, the following studies were conducted: an open, prospective noncomparative contraceptive study, an MBL study, a perimenopausal study, a study for the treatment of endometrial hyperplasia, and early cancer of the uterus, a residue study.RESULTSA total of 599 Femilis LNG-IUS were inserted in various clinical trials, the majority for contraceptive purposes. The total exposure in the first and second contraceptive studies, covering 558 parous and nulliparous women, was 32,717 woman-months. Femilis has high contraceptive effectiveness as only one pregnancy occurred. Expulsion of the LNG-IUS was rare with only two total and no partial expulsions (stem protruding through the cervical canal) occurred. Femilis was well tolerated, with continuation rates remaining high. Several MBL studies were conducted, totaling 80 heavy and normal menstrual bleeders, using the pictorial bleeding assessment chart method or the quantitative alkaline hematin technique. Virtually all women responded well with strongly reduced menstrual bleeding. Amenorrhea rates were high, up to 80% after three months, and ferritin levels simultaneously increased significantly. The Femilis LNG-IUS was tested in 104 symptomatic perimenopausal women for seamless transition to and through menopause, adding estrogen therapy when required. Patient tolerability appeared high as >80% requested a second and a third LNG-IUS. Twenty women presenting with nonatypical and atypical hyperplasia and one woman presenting with early endometrial carcinoma were treated with Femilis LNG-IUS. All histology specimens showed full regression, and patients remained in remission without signs of hyperplasia or cancer at yearly and ongoing follow-up examinations up to 10 years. Residual content of LNG was measured in 37 women having the Femilis LNG-IUS for up to 10 years. In 10 of the 102 women who had the Femilis 60 in situ for 10 years between 20% and 30% of the original 60 mg was recovered confirming the long duration of action of the Femilis 60 LNG-IUS.CONCLUSIONThese studies suggest that the Femilis 60 LNG-IUS releasing 20 µg of LNG/day is an effective, well-tolerated, and well-retained contraceptive both in parous and in nulliparous women. The design of the LNG-IUS, with flexible transverse arm(s) length of 28 mm, allows for a simplification of the insertion technique and training requirements facilitating the use by nonspecialist providers in either developed or developing countries. For nulliparous women, additional evaluation of devices with a 24 mm transverse arm(s), as it relates to tolerability, retention, and...

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“…In the presence of the uterus, maximum reduction of risk can only be achieved by eliminating exposure of circulating progestin or progesterone at the breast. The placement of a low‐dose levonorgestrel eluting intrauterine device (IUD) is the best solution to this problem . The local release of progestin prevents endometrial proliferation and, in the newer smaller devices, yields systemic progestin circulating levels in low picogram concentrations—orders of magnitude less than nanogram concentrations associated with oral MPA (2.5 mg) .…”

Section: Opportunitymentioning

confidence: 99%

Aging, the menopausal transition, and hormone replenishment therapy: retrieval of confidence and compliance

Saul

Kase

2018

Annals of the New York Academy of Sciences

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The negative health consequences of age and the postmenopausal hypoestrogenic state and their clinical management are described in this paper. While some dysfunctional elements are irreversibly entrained, others can be modified by an updated menopausal hormone therapy (MHT) strategy reflecting revision and reassessment of the initial Women's Health Initiative (WHI) reports. However, until that positive outcome is realized, menopausal women and their healthcare providers must re-establish willingness to utilize these effective strategies. This reluctance is fueled by persistent mistaken application of WHI results that reflect the bundled risk and benefits of MHT in asymptomatic women aged 50-79 (average age 63), as opposed to women in their 40s and 50s who initiate therapy because of vasomotor symptoms. The absolute risk of adverse outcomes is much lower and the benefits dramatically higher in these younger women. In addition, newer FDA-approved formulations, lower dosage regimens, and transdermal delivery methodologies offer wider choice of approaches and promise even greater safety. The positive and negative lessons of the WHI have been learned and can be applied effectively.

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Use of a levonorgestrel-containing intrauterine system with supplemental estrogen improves symptoms in perimenopausal women

Cited by 32 publications

References 27 publications

The 2020 Menopausal Hormone Therapy Guidelines

The 2020 Menopausal Hormone Therapy Guidelines

Femilis® 60 Levonorgestrel-Releasing Intrauterine System–-A Review of 10 Years of Clinical Experience

Aging, the menopausal transition, and hormone replenishment therapy: retrieval of confidence and compliance

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