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Drospirenone 4 mg in a 24 + 4 regimen in women with contraindications to oestrogen use for contraception: bleeding patterns according to previous menstrual characteristics

  • General Gynecology
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Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

A new POP consisting of 4 mg drospirenone (DRSP) for 24 days with a 4-day hormone-free interval was developed to improve bleeding predictability during POP use. The aim of this study was to evaluate the effect on bleeding patterns during use of this oral contraceptive (OC) in comparison with previous menstrual cycles before the start of OC use.

Methods

This is a pilot, prospective trial. A diary was used to collect information about daily bleeding and pelvic pain before and during treatment. During OC use, women were categorised as having (1) unscheduled bleeding or spotting days (UB), (2) scheduled bleeding or spotting days (SB) and (3) absence of bleeding/spotting (AB). SF-36 and FSFI questionnaires were used to quantify health-related quality of life and the quality of sexual life in sexually active participants.

Results

Eighteen out of twenty-five (72%) women completed the entire follow-up. Women with UB (44.4%) were older at inclusion (p < 0.001) and had higher BMIs (p = 0.02) than those with AB (22.2%) or SB (33.4%). Women recorded a significant reduction of menstrual flow intensity during OC use (p < 0.0001). Those with UB also experienced a significant reduction of menstrual pain intensity (p = 0.006). Women with SB during OC use had a longer baseline cycle than those who reported UB during OC use (p = 0.008). Satisfaction with this OC was very high (8.4 ± 2.2 points) with no modification in SF-36 and FSFI values.

Conclusion

A DRSP-only pill is a good OC option for women with contraindications to oestrogen use. Features of the menstrual cycle before the start of OC use may be used to predict associated changes in bleeding patterns.

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Data availability

Data available on request due to privacy/ethical restrictions.

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Authors and Affiliations

  1. Department of Medical and Surgical Sciences for Mother, Child and Adult, Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Via del Pozzo 71, 41124, Modena, Italy

    Giovanni Grandi, Maria Chiara Del Savio, Chiara Melotti & Fabio Facchinetti

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  1. Giovanni Grandi
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  2. Maria Chiara Del Savio
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  3. Chiara Melotti
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  4. Fabio Facchinetti
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Contributions

GG: concept and design, data analysis, interpretation, manuscript draft, final approval. MCDS: manuscript revision, final approval. CM: study execution, final approval. FF: interpretation, data analysis, manuscript revision, final approval.

Corresponding author

Correspondence to Giovanni Grandi.

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Conflict of interest

G. Grandi received honoraria for sponsored lectures and participation in advisory boards from Bayer AG, Italfarmaco, Theramex, Organon, Gedeon Richter and Exeltis, not related to this manuscript. Other authors report no conflicts of interest.

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Grandi, G., Del Savio, M.C., Melotti, C. et al. Drospirenone 4 mg in a 24 + 4 regimen in women with contraindications to oestrogen use for contraception: bleeding patterns according to previous menstrual characteristics. Arch Gynecol Obstet 307, 873–879 (2023). https://doi.org/10.1007/s00404-022-06853-1

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  • DOI: https://doi.org/10.1007/s00404-022-06853-1

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