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Endometrial safety of a novel monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen over six cycles.
Contraception. 2010 Oct; 82(4):358-65.C

Abstract

BACKGROUND

This study was conducted to examine whether small doses of ethinylestradiol (EE, 0.02 mg) and chlormadinone acetate (CMA, 2 mg) administered in a novel 24/4-day regimen during six cycles would suffice to suppress proliferation and to cause secretory changes in the endometrium.

STUDY DESIGN

This Phase II, randomized (two assessment groups), single-center, open, uncontrolled, multiple-dosing study treated 59 female subjects. The subjects underwent three endometrial biopsies: one pretreatment, one during medication (either at Cycle 3 or Cycle 6) and one during the first post-treatment cycle.

RESULTS

The study revealed that 0.02 mg EE/2 mg CMA effectively transformed the endometrium from a proliferative state into a secretory or inactive state after three (90% of subjects) and six (76% of subjects) medication cycles. The mean endometrial thickness decreased markedly from 10.2 (SD±3.0) mm (pretreatment) to an unfavorable level for the nidation of a blastocyst [5.3 (SD±2.1) and 4.1 (SD±2.2) mm in Medication Cycles 3 and 6, respectively]. Correspondingly, estradiol and progesterone levels decreased during treatment. In the post-treatment cycle, endometrial biopsy and ultrasound evaluation as well as sex hormone levels suggested a quick return to fertility. There were no signs of hyperplasia, endometrial polyps, neoplasia or other detrimental histopathological changes at any time during the trial. Treatment-related adverse events (AEs) were reported by 22 (37%) of 59 subjects and were reported most commonly in Cycle 1, decreasing continuously thereafter. No AEs led to discontinuation of the trial medication and there were no serious AEs.

CONCLUSIONS

The 24/4-day regimen of 0.02 mg EE/2 mg CMA provided effective and reversible endometrial effects with secretory transformation or suppression without inducing pathological changes.

Authors+Show Affiliations

University Women's Hospital, Heidelberg, Germany. thomas.rabe@med.uni-heidelberg.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

20851230

Citation

Rabe, Thomas, et al. "Endometrial Safety of a Novel Monophasic Combined Oral Contraceptive Containing 0.02 Mg Ethinylestradiol and 2 Mg Chlormadinone Acetate Administered in a 24/4-day Regimen Over Six Cycles." Contraception, vol. 82, no. 4, 2010, pp. 358-65.
Rabe T, Hartschuh E, Wahlstrom T, et al. Endometrial safety of a novel monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen over six cycles. Contraception. 2010;82(4):358-65.
Rabe, T., Hartschuh, E., Wahlstrom, T., Höschen, K., & König, S. (2010). Endometrial safety of a novel monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen over six cycles. Contraception, 82(4), 358-65. https://doi.org/10.1016/j.contraception.2010.04.013
Rabe T, et al. Endometrial Safety of a Novel Monophasic Combined Oral Contraceptive Containing 0.02 Mg Ethinylestradiol and 2 Mg Chlormadinone Acetate Administered in a 24/4-day Regimen Over Six Cycles. Contraception. 2010;82(4):358-65. PubMed PMID: 20851230.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Endometrial safety of a novel monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen over six cycles. AU - Rabe,Thomas, AU - Hartschuh,Elena, AU - Wahlstrom,Torsten, AU - Höschen,Kornelia, AU - König,Simone, PY - 2009/09/18/received PY - 2010/04/13/revised PY - 2010/04/14/accepted PY - 2010/9/21/entrez PY - 2010/9/21/pubmed PY - 2011/2/8/medline SP - 358 EP - 65 JF - Contraception JO - Contraception VL - 82 IS - 4 N2 - BACKGROUND: This study was conducted to examine whether small doses of ethinylestradiol (EE, 0.02 mg) and chlormadinone acetate (CMA, 2 mg) administered in a novel 24/4-day regimen during six cycles would suffice to suppress proliferation and to cause secretory changes in the endometrium. STUDY DESIGN: This Phase II, randomized (two assessment groups), single-center, open, uncontrolled, multiple-dosing study treated 59 female subjects. The subjects underwent three endometrial biopsies: one pretreatment, one during medication (either at Cycle 3 or Cycle 6) and one during the first post-treatment cycle. RESULTS: The study revealed that 0.02 mg EE/2 mg CMA effectively transformed the endometrium from a proliferative state into a secretory or inactive state after three (90% of subjects) and six (76% of subjects) medication cycles. The mean endometrial thickness decreased markedly from 10.2 (SD±3.0) mm (pretreatment) to an unfavorable level for the nidation of a blastocyst [5.3 (SD±2.1) and 4.1 (SD±2.2) mm in Medication Cycles 3 and 6, respectively]. Correspondingly, estradiol and progesterone levels decreased during treatment. In the post-treatment cycle, endometrial biopsy and ultrasound evaluation as well as sex hormone levels suggested a quick return to fertility. There were no signs of hyperplasia, endometrial polyps, neoplasia or other detrimental histopathological changes at any time during the trial. Treatment-related adverse events (AEs) were reported by 22 (37%) of 59 subjects and were reported most commonly in Cycle 1, decreasing continuously thereafter. No AEs led to discontinuation of the trial medication and there were no serious AEs. CONCLUSIONS: The 24/4-day regimen of 0.02 mg EE/2 mg CMA provided effective and reversible endometrial effects with secretory transformation or suppression without inducing pathological changes. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/20851230/Endometrial_safety_of_a_novel_monophasic_combined_oral_contraceptive_containing_0_02_mg_ethinylestradiol_and_2_mg_chlormadinone_acetate_administered_in_a_24/4_day_regimen_over_six_cycles_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(10)00150-2 DB - PRIME DP - Unbound Medicine ER -