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A comparative randomized trial on the impact of two low-dose oral contraceptives on ovarian activity, cervical permeability, and endometrial receptivity.
Contraception. 1997 Jul; 56(1):23-30.C

Abstract

In a double-blind randomized study, the suppression of ovarian activity and anti-conceptive effects on the cervix and endometrium were assessed during administration of two low-dose monophasic oral contraceptives (20 micrograms ethinyl estradiol [EE], 500 micrograms norethisterone--Eve 20 [Grünenthal, Aachen, Germany]; 20 micrograms EE, 150 micrograms desogestrel --Lovelle [Organon, Munich, Germany]). One hundred eighteen healthy women (ages: 18-35 years) were studied in 10 investigation centers during medication with either Eve 20 (n = 59) or Lovelle (n = 59). During three treatment cycles, ovarian activity was evaluated by sonographic determination of follicle-like structures (FLS) and by simultaneous assessment of serum endocrine profiles (gonadotropins LH and FSH, ovarian steroids estradiol [E2] and progesterone [P]). While on either treatment, no ovarian activity (as judged by no FLS and/or reduced sex steroid levels) was found in 90.8% (Eve 20) and 97.2% (Lovelle) of all investigated cycles. Follicular activity or cyst formation were detected in 18 of 173 cycles (Eve 20) and in 5 of 175 cycles (Lovelle), respectively. Gonadotropin levels were suppressed (LH < 6 IU/L, FSH < 8 IU/L) in most treatment cycles (Eve 20 76.6% vs. Lovelle: 84.8%). Serum E2 concentrations exceeding 0.1 nmol/L indicated residual follicular activity in 19.3% (Eve 20) versus 12.2% (Lovelle) of all cycles. An estimated by serum P levels over 5 nmol/L, ovulation had presumably occurred in 4.1% (Eve 20) versus 2.9% (Lovelle) of treatment cycles. However, when the sonographical and endocrinological data were combined, no ovulation was documented in any pill cycle. The quality and quantity of the cervical mucus was found to be minimal in the majority of women. Moreover, the endometrial layer was determined to be low by ultrasound during most pill cycles, indicating equally strong suppressive effects on endometrial receptivity by the two contraceptives. These observations suggest that ovarian activity is suppressed in the majority of cycles during use of low-dose contraceptives. This effect may mainly be medicated by pronounced suppression of serum gonadotropin levels. Strong anti-conceptive effects of these formulations on both cervical permeability and endometrial receptivity are additional factors ensuring the contraceptive efficacy of these formulations.

Authors+Show Affiliations

Department of Obstetrics-Gynecology, University of Ulm, Germany. winfried.rossmanith@medizin.uni-ulm.deNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

9306028

Citation

Rossmanith, W G., et al. "A Comparative Randomized Trial On the Impact of Two Low-dose Oral Contraceptives On Ovarian Activity, Cervical Permeability, and Endometrial Receptivity." Contraception, vol. 56, no. 1, 1997, pp. 23-30.
Rossmanith WG, Steffens D, Schramm G. A comparative randomized trial on the impact of two low-dose oral contraceptives on ovarian activity, cervical permeability, and endometrial receptivity. Contraception. 1997;56(1):23-30.
Rossmanith, W. G., Steffens, D., & Schramm, G. (1997). A comparative randomized trial on the impact of two low-dose oral contraceptives on ovarian activity, cervical permeability, and endometrial receptivity. Contraception, 56(1), 23-30.
Rossmanith WG, Steffens D, Schramm G. A Comparative Randomized Trial On the Impact of Two Low-dose Oral Contraceptives On Ovarian Activity, Cervical Permeability, and Endometrial Receptivity. Contraception. 1997;56(1):23-30. PubMed PMID: 9306028.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparative randomized trial on the impact of two low-dose oral contraceptives on ovarian activity, cervical permeability, and endometrial receptivity. AU - Rossmanith,W G, AU - Steffens,D, AU - Schramm,G, PY - 1997/7/1/pubmed PY - 1997/11/5/medline PY - 1997/7/1/entrez KW - Biology KW - Cervical Mucus KW - Cervix KW - Comparative Studies KW - Contraception KW - Contraceptive Agents, Estrogen--administraction and dosage KW - Contraceptive Agents, Female--administraction and dosage KW - Contraceptive Agents, Progestin--administraction and dosage KW - Contraceptive Agents--administraction and dosage KW - Contraceptive Methods--pharmacodynamics KW - Contraceptive Mode Of Action KW - Desogestrel--administraction and dosage KW - Developed Countries KW - Endocrine System KW - Endometrial Effects KW - Endometrium KW - Ethinyl Estradiol--administraction and dosage KW - Europe KW - Family Planning KW - Genitalia KW - Genitalia, Female KW - Germany KW - Gonadotropins KW - Gonadotropins, Pituitary KW - Hormones KW - Norethindrone--administraction and dosage KW - Oral Contraceptives, Low-dose--pharmacodynamics KW - Oral Contraceptives--pharmacodynamics KW - Ovarian Effects KW - Ovary KW - Ovulation Suppression KW - Physiology KW - Research Methodology KW - Research Report KW - Studies KW - Urogenital System KW - Uterus KW - Western Europe SP - 23 EP - 30 JF - Contraception JO - Contraception VL - 56 IS - 1 N2 - In a double-blind randomized study, the suppression of ovarian activity and anti-conceptive effects on the cervix and endometrium were assessed during administration of two low-dose monophasic oral contraceptives (20 micrograms ethinyl estradiol [EE], 500 micrograms norethisterone--Eve 20 [Grünenthal, Aachen, Germany]; 20 micrograms EE, 150 micrograms desogestrel --Lovelle [Organon, Munich, Germany]). One hundred eighteen healthy women (ages: 18-35 years) were studied in 10 investigation centers during medication with either Eve 20 (n = 59) or Lovelle (n = 59). During three treatment cycles, ovarian activity was evaluated by sonographic determination of follicle-like structures (FLS) and by simultaneous assessment of serum endocrine profiles (gonadotropins LH and FSH, ovarian steroids estradiol [E2] and progesterone [P]). While on either treatment, no ovarian activity (as judged by no FLS and/or reduced sex steroid levels) was found in 90.8% (Eve 20) and 97.2% (Lovelle) of all investigated cycles. Follicular activity or cyst formation were detected in 18 of 173 cycles (Eve 20) and in 5 of 175 cycles (Lovelle), respectively. Gonadotropin levels were suppressed (LH < 6 IU/L, FSH < 8 IU/L) in most treatment cycles (Eve 20 76.6% vs. Lovelle: 84.8%). Serum E2 concentrations exceeding 0.1 nmol/L indicated residual follicular activity in 19.3% (Eve 20) versus 12.2% (Lovelle) of all cycles. An estimated by serum P levels over 5 nmol/L, ovulation had presumably occurred in 4.1% (Eve 20) versus 2.9% (Lovelle) of treatment cycles. However, when the sonographical and endocrinological data were combined, no ovulation was documented in any pill cycle. The quality and quantity of the cervical mucus was found to be minimal in the majority of women. Moreover, the endometrial layer was determined to be low by ultrasound during most pill cycles, indicating equally strong suppressive effects on endometrial receptivity by the two contraceptives. These observations suggest that ovarian activity is suppressed in the majority of cycles during use of low-dose contraceptives. This effect may mainly be medicated by pronounced suppression of serum gonadotropin levels. Strong anti-conceptive effects of these formulations on both cervical permeability and endometrial receptivity are additional factors ensuring the contraceptive efficacy of these formulations. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/9306028/A_comparative_randomized_trial_on_the_impact_of_two_low_dose_oral_contraceptives_on_ovarian_activity_cervical_permeability_and_endometrial_receptivity_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S001078249700070X DB - PRIME DP - Unbound Medicine ER -