Contraceptive Efficacy of a Depot Progestin and Androgen Combination in Men

Turner, Leo; Conway, Ann J.; Jimenez, Mark; Liu, Yang; Forbes, Elise A; McLachlan, Robert I; Handelsman, David J.

doi:10.1097/01.ogx.0000119179.19287.bd

Cited by 11 publications

(21 citation statements)

References 6 publications

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“…These observations have since been replicated with a longer-acting testosterone preparation [8, 11], and also using an androgen-progestin combination [12] suggesting the generalizability of this approach. The contraceptive efficacy of these preparations and regimens are summarized in Table 2.…”

Section: Mhc Methods Are Effectivementioning

confidence: 86%

“…Modern androgen and androgen-progestin combinations report suppressibility in 80–95%, of men in clinical trials lasting up to 24 months [7, 11, 12]. Whether MHC methods can be universally applied to all men is not known, and cannot be determined until lead candidate regimens have been fully optimized and tested in large-scale clinical trials equivalent to the requirement of a new female contraceptive method.…”

Section: The Universal Suppressibility Of Spermatogenesis and Applmentioning

confidence: 99%

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Recent methodological advances in male hormonal contraception

Liu¹,

Swerdloff²,

Wang³

2010

Contraception

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Landmark WHO-sponsored trials showed decades ago that male hormonal contraception (MHC) is an effective male-directed contraceptive approach. Considerable progress has been made particularly in the last 5 years, establishing for the first time the reversibility of MHC and its short-term safety. Methodological advances in recent years include: the pooling of information and individual-level integrated analysis; the first-time use of centralized semen analysis and fluorescence to detect low sperm concentrations; the establishment of sperm quality reference ranges in fertile men; the measurement of blood steroid concentrations by gas or chromatography/mass spectrometry; and the inclusion of placebo groups to delineate clearly possible adverse effects of androgens and progestins in men. We report integrated analyses of factors that are important in predicting suppression and recovery of spermatogenesis after MHC clinical trials for the past 15 years. These are the best data available and will provide guidance and reassurance for the larger scale Phase III specific regimen efficacy studies that will be required to bring MHC to the population (market).

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Section: Mhc Methods Are Effectivementioning

confidence: 86%

Section: The Universal Suppressibility Of Spermatogenesis and Applmentioning

confidence: 99%

Recent methodological advances in male hormonal contraception

Liu¹,

Swerdloff²,

Wang³

2010

Contraception

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“…We have identified three independent predictors of the degree of sperm suppression and the likelihood of achieving a sperm concentration below 1 million/ml, the threshold below which contraceptive efficacy seems likely (2,28,29). These factors were 1) the dosage of T, 2) the suppression of serum LH below 5% of control levels, and 3) the use of progestin at any dose.…”

Section: Discussionmentioning

confidence: 95%

Relationship between Serum Gonadotropins and Spermatogenic Suppression in Men Undergoing Steroidal Contraceptive Treatment

McLachlan

Robertson

Pruysers

et al. 2004

The Journal of Clinical Endocrinology & Metabolism

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This study aimed to establish whether the degree of suppression of serum FSH and LH was related to sperm concentration in three testosterone (T) plus progestin contraceptive regimens. We measured serum FSH and LH using a modified, highly sensitive immunofluorometric assay in samples obtained from three published studies using T enanthate (TE; 100 and 200 mg weekly) plus daily oral doses of cyproterone acetate (CPA; 5-100 mg), levonogestrel (LNG; 150-500 micro g), or desogestrel (DSG; 150-300 micro g). Overall, men with sperm concentrations below 0.1 million/ml had significantly lower gonadotropin levels (serum FSH, approximately 0.12 IU/liter; serum LH, approximately 0.05 IU/liter) than oligospermic men (sperm concentrations, 0.1-5 million/ml; serum FSH, 0.23-0.5 IU/liter; serum LH, 0.05-0.56 IU/liter), but the relationship was weak, indicating the possible existence of other determinants. Multivariate logistic regression was used to identify the influence of candidate predictors of spermatogenic effects of the T plus progestin regimens. In the LNG and DSG studies, the marked suppression of serum LH to less than 5% of baseline values (<0.15 IU/liter) was a consistent and highly significant predictor of sperm concentration (reduced to 2-7% that seen at higher LH levels) and the likelihood of its suppression below 1 million/ml (a proposed threshold for contraceptive efficacy). Serum FSH was not a significant independent predictor. The use of DSG and CPA (but not LNG) was a significant independent predictor of sperm suppression, and regimens that contained 200 mg TE weekly caused less spermatogenic suppression than 100 mg TE weekly. These findings suggest that T-progestin contraceptive regimens suppress sperm concentration by gonadotropin-dependent and -independent mechanisms. The suppression of serum LH is a major predictor of the suppression of sperm concentration suppression in the LNG and DSG treatment studies. On the other hand, the greater spermatogenic suppression in regimens containing DSG or CPA suggests that these progestins have additional actions to suppress spermatogenesis via a gonadotropin-independent mechanism(s)

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“…medroxyprogesterone acetate, levonorgestrel, desogestrel and norethisterone). These studies showed more rapid suppression of sperm production to very low levels (19–24) and contraceptive efficacy (25, 26). …”

Section: Introductionmentioning

confidence: 96%

Hormonal approaches to male contraception

Wang

Swerdloff

2010

Current Opinion in Urology

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Purpose of review-Condoms and vasectomy are male controlled family planning methods but suffer from limitations in compliance (condoms) and limited reversibility (vasectomy); thus many couples desire other options. Hormonal male contraceptive methods have undergone extensive clinical trials in healthy men and shown to be efficacious, reversible and appear to be safe.Recent Findings-The success rate of male hormonal contraception using injectable testosterone alone is high and comparable to methods for women. Addition of progestins to androgens improved the rate of suppression of spermatogenesis. Supported by government or nongovernment organizations, current studies aim to find the best combination of testosterone and progestins for effective spermatogenesis suppression and to explore other delivery methods for these hormones. Translation of these advances to widespread use in the developed world will need the manufacturing and marketing skills of the pharmaceutical industry. Availability of male contraceptives to the developing world may require commitments of governmental and nongovernmental agencies. In a time when imbalance of basic resources and population needs are obvious, this may prove to be a very wise investment.Summary-Male hormonal contraception is efficacious, reversible and safe for the target population of younger men in stable relationships. Suppression of spermatogenesis is achieved with a combination of an androgen and a progestin. Partnership with industry will accelerate the marketing of a male hormonal contraceptive. Research is ongoing on selective androgen and progesterone receptor modulators that suppress spermatogenesis, minimize potential adverse events while retaining the androgenic actions.

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Contraceptive Efficacy of a Depot Progestin and Androgen Combination in Men

Cited by 11 publications

References 6 publications

Recent methodological advances in male hormonal contraception

Recent methodological advances in male hormonal contraception

Relationship between Serum Gonadotropins and Spermatogenic Suppression in Men Undergoing Steroidal Contraceptive Treatment

Hormonal approaches to male contraception

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