Double-blind controlled trial of progesterone vaginal cream treatment for cyclical mastodynia in women with benign breast disease

Abstract

The clinical effectiveness and safety of vaginal micronized progesterone treatment in mastodynia were evaluated in a double-blind placebo controlled study. Eighty regularly menstruating women affected by severe cyclical mastodynia were randomly assigned to two groups of 40 patients. One group was treated for 6 cycles from the 19th to the 25th day of the cycle with 4 g of vaginal cream containing 2.5% natural progesterone. The other group was similarly treated with placebo. The treatment was preceded by a control cycle. All patients reported every day their breast pain on a 100 mm visual linear analogue scale (VAS). The response of breast tenderness and nodularity to treatment was assessed by clinical examination. Vaginal progesterone resulted significantly more efficacious than placebo in reducing mean ratings of breast pain on VAS and mean scores of breast tenderness to touch. Success of treatment, defined as reduction greater than 50% of basal mean score of breast pain on VAS, was achieved in the 64.9% of patients treated with progesterone and in the 22.2% of patients receiving placebo (p < 0.01). Conversely, at the end of treatment, the improvement in breast nodularity showed a not statistically significant difference between the two groups. No major side-effects were detected.

Evaluation and Management of Breast Pain

“…174 Micronized progesterone vaginal cream reduced breast pain and tenderness in 65% of women in the active treatment group compared with 22% in the placebo group (P<.01). 175 Progesterone cream applied to the breast was not better than placebo for cyclic breast pain in another small randomized study. 176 Danazol and Gestrinone.-Danazol, the only medication approved by the Food and Drug Administration for treatment of mastalgia, is a derivative of 17-α-ethinyl testosterone that suppresses gonadotropin secretion, prevents luteinizing hormone surge, and inhibits ovarian steroid formation.…”

Effects progestogel for postpartum engorgement of the breast

“…В частности, повышение концентрации прогестерона в межклеточном пространстве молочной железы снижает секре-торную активность пролактина через блокиро-вание в секреторных клетках рецепторов к про-лактину. Кроме того, прогестерон понижает отечность железистой ткани за счет уменьше-ния выхода жидкости из кровеносных капилля-ров [9]. Таким образом, в результате снижения образования молока и отечности при нанесе-нии прожестожеля нагрубание молочных желез…”

Efficacy of micronised vaginal progesterone versus oral dydrogestrone in the treatment of irregular dysfunctional uterine bleeding: A pilot randomised controlled trial

“…Although there are many studies investigating the effects of micronised vaginal progesterone in luteal phase support, 9–25 in the treatment of endometrial hyperplasia, 26 secondary amenorrhoea, 5 cyclical mastodynia, 27 threatened abortion 28 and menopausal symptoms, 29–31 information on the efficacy of these medications in the treatment of irregular DUB is scanty.…”