Combined oral contraceptives are recommended for heavy menstrual bleeding in patients with need for contraception and no contraindications for combined hormonal contraception, and who do not want levonorgestrel-releasing intrauterine system.
An analysis 2 from two identically designed randomized, placebo-controlled, multiple center studies conducted in Europe, Australia and North America assessed the effectiveness of combined oral contraceptive (COC with estradiol valerate plus dienogest) in reducing menstrual blood loss (MBL) in women with objectively confirmed heavy menstrual bleeding. Women aged≥ 18 years were randomized to COC (n=220) or placebo (n=135) for 7 treatment cycles. At study end, the proportion of women successfully treated (MBL below 80 mL and ≥ 50% reduction in MBL) with COC and placebo were 63.6% and 11.9%, respectively; with 68.2% and 15.6% of women with MBL below 80 mL, and 70.0% and 17.0% with MBL reduction ≥ 50% (all p<.001).
A Cochrane review [Abstract] 1 included 8 trials involving 805 participants. COC improved response to treatment (return to menstrual 'normality') and lowered MBL (table T1) when compared to placebo. Minor adverse events, in particular breast pain, were more common with COC. The Levonorgestrel-releasing intrauterine system was more effective than COC in reducing MBL (OR 0.21, 95% CI 0.09 to 0.48; 2 trials; n=151). The study found no significant difference between groups treated with oral contraceptives, mefenamic acid, low dose danazol or naproxen.
| Outcome | Relative effect (95% CI) | Risk with placebo | Risk with COC (95% CI) | №of participants (studies) |
|---|---|---|---|---|
| Response to treatment assessed with: return to complete menstrual normality (modified alkaline haematin method) follow up: mean 6 months | OR 22.12 (4.40 to 111.12) | 29 per 1,000 | 401 per 1,000 (118 to 771) | 363 (2) |
| Improvement in MBL (participant assessment) follow up: mean 6 months | OR 5.15 (3.16 to 8.40) | 424 per 1,000 | 791 per 1,000 (699 to 861) | 339 (2) |
| Adverse events follow up: mean 6 months | OR 2.17 (1.34 to 3.50) | 354 per 1,000 | 543 per 1,000 (423 to 657) | 411 (2) |
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