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The fibroadenoma is considered as a manifestation of aberration in normal development and involution (ANDI); however, its exact etiopathogenesis is poorly understood. We investigated the role of oestrogen (ER) and progesterone receptors (PR) in Fibroadenoma, to assess the ER and PR expression in epithelium and stroma of fibroadenoma and to co-relate this expression with the response to centchroman therapy. Fifty ladies with 65 fibroadenomas were investigated. Tissue from core biopsy of lesions was stained for estimating the ER and PR expression in the epithelial cells and in stroma. Patients received tablet centchroman 30 mg daily for 3 months, and the response to therapy was evaluated. A regression ≥ 30% in largest dimension of fibroadenoma on sonography was considered a significant response. The association between the response and ER and PR expression in epithelium and stroma was assessed. In the epithelium: ER positivity = 62.5%; PR positivity = 93.75%. In the stroma, the ER positivity = 2% and PR positivity = 8.3%. Response to centchroman was observed in 33/48 = 68.7%. Among the 33 responders, 23 lesions expressed ER in epithelium, while 10 lesions were ER negative. The relative risk of regression with "ER positivity of epithelium" as exposure = 1.38 (95% CI; 1.35–1.40, p = 0.12). Among responders, 30/33 exhibited PR positivity in epithelium. Expression of ER and PR in the epithelium of fibroadenoma is associated with significant regression in size with 3 months of therapy with centchroman. [ABSTRACT FROM AUTHOR]

Cyclical mastalgia of moderate to severe degree requires systemic drug therapy. Tamoxifen is the drug of choice worldwide. A novel molecule, centchroman/Ormeloxifene, developed in India, was found to be equally effective in previous studies. However, its optimal dose regimen is uncertain. We conducted three-arm randomized controlled trial to compare the effectiveness in relieving breast pain. Group 1 received tamoxifen 10 mg daily, and groups 2 and 3 received centchroman 30 mg twice and 30 mg thrice a week, respectively, for 3 months with a follow-up of 3 more months. Breast pain score, nodularity score, sonographic evaluation of the breasts and ovaries, quality of life scores, and adverse events were recorded. The number of patients enrolled was 32, 31, and 30 in group 1, group 2, and group 3, respectively. All three groups had significant improvement in breast pain scores [group 1 (5 → 2), group 2 (5 → 2), group 3 (6 → 2), p < 0.001)], nodularity scores [group1 (1 → 0), group 2 (1 → 0), group 3 (1 → 0), p < 0.001)] and in the quality of life scores over time. However, no significant differences were observed in-between the groups. Transient ovarian cyst formation and menstrual irregularities were more common with a higher dose of centchroman. Centchroman in the dosages of 30 mg twice or thrice a week is as effective as a daily dose of tamoxifen 10 mg in relieving pain, nodularity, and improving quality of life scores. The dose of centchroman 30 mg twice a week for 12 weeks has the least adverse effects and should be accepted as the optimal dosage regimen. There is a need of further study with a greater number of participants and longer follow-up. Trial registration number: CTRI/2018/02/012043 (Registered on: 21/02/2018). [ABSTRACT FROM AUTHOR]