Cited by 18Reproductive Health and ContraceptionOvarian function and disordersReproductive Biology and Fertility

Ovarian function during and after treatment with the new progestagen Org 30659

Open access
Obruca, Andreas, Korver, Tjeerd, Huber, Johannes, Killick, Stephen R, Landgren, Britt-Marie, Struijs, Martin J·2001·Fertility and Sterility

Abstract

Objective To evaluate ovarian function during 21 days of oral administration of different doses of Org 30659, a novel selective progestagenic steroid.Design Randomized, double-blind, dose-finding study.Settings Three centers in Austria, Sweden, and the United Kingdom.Participants Eighty-one healthy women 19-40 years of age with regular ovulatory cycles.Intervention Daily oral administration of 0.060, 0.120, 0.180, or 0.240 mg of Org 30659, or 0.075 mg desogestrel (reference group), for 21 days.Main outcome measure(s) Once-daily measurements of follicular diameter and 17-beta estradiol, progesterone, FSH, and LH levels.Result(s) Daily treatment with Org 30659 for 21 days caused dose-dependent suppression of ovarian activity. No ovulation was observed in any study group. On average, ovulation returned 16.5 to 22.1 days after treatment. The effects of desogestrel, 0.075 mg, were similar to those of 0.060 and 0.120 mg of Org 30659. All doses were well tolerated, as shown by the type of side effects that occurred, the absence of an effect on physical and laboratory findings, and the low rate of study discontinuation.Conclusion(s) Daily oral administration of 0.060-0.240 mg of Org 30659 suppresses ovarian function to a level sufficient to inhibit ovulation. This effect is dose-dependent, and the suppressive effect is readily reversible at all doses tested. Org 30659 can thus be safely administered orally for 21 days to healthy female volunteers in a dosage of 0.060 mg/d to 0.240 mg/d.

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Crossref · 10.1016/s0015-0282(01)01824-6

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  • A modified menstrual cycle model based on the Margolskee 2011 model was used with optimal control theory to determine the minimum total exogenous estrogen/progesterone dose and timing of administration to induce anovulation.

    “Utilized optimal control theory on a modified menstrual cycle model (based on Margolskee 2011 model) to determine the minimum total exogenous estrogen/progesterone dose and timing of administration to induce anovulation (absence of ovulation)”

    From A Survey of Mathematical Modeling of Hormonal Contraception and the Menstrual Cycle (2024) · cites this paper as [11]

    The conclusion (FERTILITY & STERILITY section; page not provided) reports that daily doses of Org 30659 inhibited ovulation. It does not report using a Margolskee-based menstrual-cycle model or optimal control theory to determine a minimum combined estrogen/progesterone dose or its timing; searches for those methods found no supporting passage. (LLM, conf=0.82)

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  • Two major changes were made to the original Harris Clark 2003 and Margolskee 2011 models to simulate contraceptive behavior that is consistent with the biology.

    “Made two major changes to the original models (Harris Clark 2003 and Margolskee 2011) to simulate contraceptive behavior that is consistent with the biology.”

    From A Survey of Mathematical Modeling of Hormonal Contraception and the Menstrual Cycle (2024) · cites this paper as [11]

    The Discussion describes the biological effects of progestagens on ovarian function, and the conclusion reports dose-dependent inhibition of ovulation; neither addresses changes to simulation models. Searches for Harris Clark, Margolskee, and contraceptive-behavior modeling found no relevant passage in our copy. (LLM, conf=0.76)

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  • In a new model, P_app limits early follicle development and is enhanced by E2.

    “In this new model, . P app limits early follicle development and is enhanced by E . 2”

    From A Survey of Mathematical Modeling of Hormonal Contraception and the Menstrual Cycle (2024) · cites this paper as [11]

    The Discussion describes reduced follicular growth after selection of the dominant follicle during progestagen treatment and says E2 facilitates follicular development. Searches for “P_app” and a new model of early follicle development found no passage saying that P_app limits early development or is enhanced by E2. No page numbers were available in our copy. (LLM, conf=0.76)

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Research works printed but not linked: 1

  1. Hackeloer BJ, Fleming R, Robinson HP, Adam AH, Coults JR. Cor- relation of ultrasonic and endocrinologic assessment of human follic- ular development. Am J Obstet Gynecol 1979;135:122-8.

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Authors
Obruca, A., Korver, T., Huber, J., Killick, S. R., Landgren, B.-M., & Struijs, M. J.
Affiliations
  • University of Vienna (AT)
  • Karolinska Institutet (SE)
Corresponding author
Korver, Tjeerd
Venue
Fertility and Sterility
Publisher
Elsevier BV
Published
2001-07
Volume
76
Issue
1
Pages
108-115
ISSN
0015-0282 (ISSN-L)
OpenAlex
W1998384584
Cited by
18
References
22
Citations by year
2026: 1 · 2025: 2 · 2024: 2 · 2023: 2 · 2022: 1 · 2021: 1 · 2020: 1 · 2019: 1
FWCI
0.78
Type
journal article
Language
en
Open access
Locations
  • Fertility and Sterility (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
  • Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Biology and Fertility
Keywords
ovarian function, ovulation inhibition, dose-dependent effects, desogestrel, follicle size, estradiol, progesterone, follicle-stimulating hormone, luteinizing hormone, oral progestogens, healthy women
MeSH terms
Adult, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Norethindrone, Ovary, Ovulation, Progestins, Ultrasonography, Desogestrel, Progesterone Congeners

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