Utrogestan

What it is:

Utrogestan contains micronized (body-identical) progesterone, structurally identical to progesterone produced naturally by the body.

What the clinical trial evidence shows

Endometrial protection: A systematic review of 40 studies confirmed oral micronised progesterone reliably protects the womb lining at the standard sequential dose [9]. This is its primary license.

Sleep: A 2021 systematic review and meta-analysis of 9 RCTs found improvements in how quickly women fell asleep with micronised progesterone, though effects on total sleep time did not reach statistical significance. Most women reported better sleep on progesterone [10].

Hot flushes and night sweats: A 2023 Phase III RCT specifically in perimenopausal women tested progesterone alone (300mg) vs placebo. The primary  outcome for hot flushes and night sweats did not reach significance, and the trial was underpowered, but women reported significant improvements in night sweats and sleep quality as perceived outcomes [11].

Breast cancer and VTE: A 2018 systematic review (Stute et al.) found no increase in breast cancer risk for up to 5 years of use with micronised progesterone [12]. The BMS states there may be a lower risk of VTE and breast cancer with micronised progesterone than with older synthetic progestogens [5].

What guidelines say

NICE recommends HRT, including combined oestrogen plus progestogen, as the most effective treatment for menopausal symptoms in women without contraindications [3]. For women with a womb, a progestogen must be added to oestrogen to protect the womb lining; micronised progesterone is one of the named options.

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References

[1] Exeltis UK Ltd. Gepretix 100mg/200mg soft capsules — Summary of Product Characteristics. 2025. Available at: https://www.medicines.org.uk/emc/product/14948/smpc. No PMID (regulatory document).

[2] Exeltis UK Ltd. Gepretix HCP Hub. 2025. Available at: https://exeltishub.co.uk/hcp/menopause/gepretix/. No PMID (company promotional material, HCP use only).

[3] National Institute for Health and Care Excellence. Menopause: Identification and Management. NICE Guideline NG23. 2015, updated November 2024. Available at: https://www.nice.org.uk/guidance/ng23. No PMID (clinical guideline).

[4] Hamoda H et al. on behalf of the BMS Medical Advisory Council. British Menopause Society Tools for Clinicians: Progestogens and Endometrial Protection. Post Reprod Health 2022;28:10-25. PMID: 34841960. https://pubmed.ncbi.nlm.nih.gov/34841960/

[5] British Menopause Society. Statement Regarding Progestogens. June 2023. Available at: https://thebms.org.uk/2023/06/statement-regarding-progestogens/. No PMID (clinical guideline/statement).

[6] British Menopause Society / Women's Health Concern. BMS-WHC Consensus Statement: Recommendations on HRT in Menopausal Women. 2023, updated September 2025. Available at: https://thebms.org.uk. No PMID (clinical guideline).

[7] The North American Menopause Society Advisory Panel. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. Menopause 2022;29(7):767–794. PMID: 35797481. https://pubmed.ncbi.nlm.nih.gov/35797481/

[8] de Villiers TJ et al. Revised Global Consensus Statement on Menopausal Hormone Therapy. Climacteric 2016;19(4):313–315. No PMID (consensus statement). Available at: https://doi.org/10.1080/13697137.2016.1196047.

[9] Stute P, Neulen J, Wildt L. The impact of micronized progesterone on the endometrium: a systematic review. Climacteric 2016;19(4):316–328. PMID: 27277331. https://pubmed.ncbi.nlm.nih.gov/27277331/

[10] Nolan BJ, Liang B, Cheung AS. Efficacy of Micronized Progesterone for Sleep: A Systematic Review and Meta-analysis of Randomized Controlled Trial Data. J Clin Endocrinol Metab 2021;106(4):942–951. PMID: 33245776. https://pubmed.ncbi.nlm.nih.gov/33245776/

[11] Prior JC et al. Oral micronized progesterone for perimenopausal night sweats and hot flushes: a Phase III Canada-wide randomized placebo-controlled 4-month trial. Scientific Reports 2023;13(1):9082. PMID: 37277418. https://pubmed.ncbi.nlm.nih.gov/37277418/

[12] Stute P, Wildt L, Neulen J. The impact of micronized progesterone on breast cancer risk: a systematic review. Climacteric 2018;21(2):111–122. PMID: 29384406. https://pubmed.ncbi.nlm.nih.gov/29384406/

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