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Suppression of ovarian function by a combined oral contraceptive containing 0.02 mg ethinyl estradiol and 2 mg chlormadinone acetate given in a 24/4-day intake regimen over three cycles.
Fertil Steril. 2010 Sep; 94(4):1195-201.FS

Abstract

OBJECTIVE

To describe the suppression of ovarian function with 0.02 mg ethinyl E(2)-2 mg chlormadinone acetate administered in a 24/4-day intake regimen in healthy women.

DESIGN

Open, uncontrolled, multiple dosing, phase II trial.

SETTING

Single clinic.

PATIENT(S)

Forty women treated.

INTERVENTION(S)

Treatment for up to three cycles with 0.02 mg ethinyl E(2)-2 mg chlormadinone acetate given in a 24/4-day regimen.

MAIN OUTCOME MEASURE(S)

Assessments of ovarian function classified by the Hoogland and Skouby score, thickness of endometrium, cervical reaction, and sex hormone levels, as well as overall tolerability.

RESULT(S)

No ovulation was observed in the per protocol set (N=36), and one in the full analysis set (N=38) after vomiting and diarrhea. Absence of ovarian activity, residual ovarian activity, and formation of a luteinized unruptured follicle were observed in 75.0%, 15.9%, and 1.1% of medication cycles, respectively. Endometrial thickness was suppressed to 4 to 5 mm compared with 10 to 12 mm without medication. Cervical reaction was negative. Hormone levels were lower with medication than without, and the medication was well tolerated. Treatment-related adverse events were typical of those associated with hormonal contraceptive use.

CONCLUSION(S)

Follicular development, cervical reaction, and endometrial thickness were suppressed profoundly after 0.02 mg ethinyl E(2)-2 mg chlormadinone acetate administration in a 24/4-day regimen, resulting in inhibition of ovulation and unfavorable conditions for fertilization, implantation, and thus pregnancy.

Authors+Show Affiliations

Vitalogic GmbH, Vienna, Austria. juergen.spona@vitalogic.atNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19709656

Citation

Spona, Jürgen, et al. "Suppression of Ovarian Function By a Combined Oral Contraceptive Containing 0.02 Mg Ethinyl Estradiol and 2 Mg Chlormadinone Acetate Given in a 24/4-day Intake Regimen Over Three Cycles." Fertility and Sterility, vol. 94, no. 4, 2010, pp. 1195-201.
Spona J, Binder N, Höschen K, et al. Suppression of ovarian function by a combined oral contraceptive containing 0.02 mg ethinyl estradiol and 2 mg chlormadinone acetate given in a 24/4-day intake regimen over three cycles. Fertil Steril. 2010;94(4):1195-201.
Spona, J., Binder, N., Höschen, K., & Feichtinger, W. (2010). Suppression of ovarian function by a combined oral contraceptive containing 0.02 mg ethinyl estradiol and 2 mg chlormadinone acetate given in a 24/4-day intake regimen over three cycles. Fertility and Sterility, 94(4), 1195-201. https://doi.org/10.1016/j.fertnstert.2009.06.057
Spona J, et al. Suppression of Ovarian Function By a Combined Oral Contraceptive Containing 0.02 Mg Ethinyl Estradiol and 2 Mg Chlormadinone Acetate Given in a 24/4-day Intake Regimen Over Three Cycles. Fertil Steril. 2010;94(4):1195-201. PubMed PMID: 19709656.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Suppression of ovarian function by a combined oral contraceptive containing 0.02 mg ethinyl estradiol and 2 mg chlormadinone acetate given in a 24/4-day intake regimen over three cycles. AU - Spona,Jürgen, AU - Binder,Natascha, AU - Höschen,Kornelia, AU - Feichtinger,Wilfried, Y1 - 2009/08/25/ PY - 2009/04/17/received PY - 2009/06/22/revised PY - 2009/06/25/accepted PY - 2009/8/28/entrez PY - 2009/8/28/pubmed PY - 2010/9/21/medline SP - 1195 EP - 201 JF - Fertility and sterility JO - Fertil. Steril. VL - 94 IS - 4 N2 - OBJECTIVE: To describe the suppression of ovarian function with 0.02 mg ethinyl E(2)-2 mg chlormadinone acetate administered in a 24/4-day intake regimen in healthy women. DESIGN: Open, uncontrolled, multiple dosing, phase II trial. SETTING: Single clinic. PATIENT(S): Forty women treated. INTERVENTION(S): Treatment for up to three cycles with 0.02 mg ethinyl E(2)-2 mg chlormadinone acetate given in a 24/4-day regimen. MAIN OUTCOME MEASURE(S): Assessments of ovarian function classified by the Hoogland and Skouby score, thickness of endometrium, cervical reaction, and sex hormone levels, as well as overall tolerability. RESULT(S): No ovulation was observed in the per protocol set (N=36), and one in the full analysis set (N=38) after vomiting and diarrhea. Absence of ovarian activity, residual ovarian activity, and formation of a luteinized unruptured follicle were observed in 75.0%, 15.9%, and 1.1% of medication cycles, respectively. Endometrial thickness was suppressed to 4 to 5 mm compared with 10 to 12 mm without medication. Cervical reaction was negative. Hormone levels were lower with medication than without, and the medication was well tolerated. Treatment-related adverse events were typical of those associated with hormonal contraceptive use. CONCLUSION(S): Follicular development, cervical reaction, and endometrial thickness were suppressed profoundly after 0.02 mg ethinyl E(2)-2 mg chlormadinone acetate administration in a 24/4-day regimen, resulting in inhibition of ovulation and unfavorable conditions for fertilization, implantation, and thus pregnancy. SN - 1556-5653 UR - https://www.unboundmedicine.com/medline/citation/19709656/Suppression_of_ovarian_function_by_a_combined_oral_contraceptive_containing_0_02_mg_ethinyl_estradiol_and_2_mg_chlormadinone_acetate_given_in_a_24/4_day_intake_regimen_over_three_cycles_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0015-0282(09)01431-9 DB - PRIME DP - Unbound Medicine ER -