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Whitaker LHR, Middleton LJ, Priest L, et al. Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding: the UCON randomised controlled trial and mechanism of action study. Southampton (UK): National Institute for Health and Care Research; 2023 Oct. (Efficacy and Mechanism Evaluation, No. 10.08.)

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Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding: the UCON randomised controlled trial and mechanism of action study.

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Appendix

TABLE 18

TABLE 18

MMAS scores in the secondary population B1

TABLE 19

TABLE 19

MMAS scores in the secondary population B2

TABLE 20

TABLE 20

MMAS scores – sensitivity analysis (12 months only)

TABLE 21

TABLE 21

MMAS scores – heterogeneity over recruitment period for population A

TABLE 22

TABLE 22

PBAC bleeding diary scores in secondary population B1

TABLE 23

TABLE 23

PBAC bleeding diary scores in secondary population B2

TABLE 24

TABLE 24

Clinical measurement via pelvic ultrasound/blood sample at 12 months in the secondary population B1

TABLE 25

TABLE 25

Clinical measurement via pelvic ultrasound/blood sample at 12 months in the secondary population B2

TABLE 26

TABLE 26

Adverse events (MedDRA categorisation)

TABLE 27

TABLE 27

Median alteration in DCE-MRI parameters within uterine myometrium across all patients

TABLE 28

TABLE 28

Median alteration in DCE-MRI parameters within the endometrium across all patients

TABLE 29

TABLE 29

Median alteration in DCE-MRI parameters within uterine fibroids across all patients with fibroids

FIGURE 24. Plot of MMAS categories by assessment time (M = months).

FIGURE 24

Plot of MMAS categories by assessment time (M = months).

FIGURE 25. Scatterplot of PBAC scores vs.

FIGURE 25

Scatterplot of PBAC scores vs. MMAS scores by assessment time.

FIGURE 26. Boxplot of PBAC scores by group and assessment time, incorporating UPA responses.

FIGURE 26

Boxplot of PBAC scores by group and assessment time, incorporating UPA responses.

Copyright © 2023 Whitaker et al.

This work was produced by Whitaker et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

Bookshelf ID: NBK596822
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