Oral Contraceptive Therapy and Sexuality

NCT02613039 | Completed Phase 4

• 1 other identifier: ANDRO-AOUC-2015-2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Oral contraceptives (OCs) ameliorate hyperandrogenism and regulate menstrual cycles. To reduce androgenic side effects of first- and second-generation progestins, several new progestins derived from progesterone or spironolactone have been developed in the last few decades. These progestins, such as drospirenone, cyproterone acetate and NOMAC, are designed to bind specifically to the progesterone receptor and to have no androgenic, estrogenic or glucocorticoid actions. However, OCs with a more pronounced anti-androgenic effects are more likely to induce sexual dysfunction, mainly hypoactive sexual desire disorder, which can highly impact patient and partner's quality of life. Moreover, available data indicate that OC use might increase adiposity in adolescents and might be associated with central redistribution of body fat in young women with Polycystic ovary syndrome (PCOS) without a recognizable difference in clinical anthropometric measurements, including body mass index and waist circumference. In this context, it would be worth to evaluate the effects of combined OCs on metabolic and sexual health (sexual desire, arousal, and other parameters of sexual health), body image and mood.

Conditions

Contraceptive Usage; Sexual Behavior; Mental Health Wellness 1

Keywords

oral contraceptives; female sexuality

Outcome Measures

Primary Outcomes (3)

• Changes in sexual function (FSFI score)

  A significant difference in FSFI score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.

  6 months and 12 months

• Changes in sexual distress (FSDS score)

  A significant difference in FSDS score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.

  6 months and 12 months

• Changes in clitoris vascularization

  A significant difference in clitoris artery hemodynamic parameters evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.

  6 months and 12 months

Secondary Outcomes (16)

• Changes in body image perception

  6 months and 12 months

• Changes in mood and mental status

  6 months and 12 months

• Changes in glycaemia

  6 months and 12 months

• Changes in glycated hemoglobin (HbA1c) levels

  6 months and 12 months

• Changes in insulin levels

  6 months and 12 months

Study Arms (1)

female outpatient subjects

OTHER

Patients requiring combined Oral Contraceptives therapy.

Drug: Combined Estrogen-Progestin Oral Contraceptives

Interventions

Combined Estrogen-Progestin Oral Contraceptives DRUG

All patients enrolled will undergo Combined Estrogen-Progestin Oral Contraceptives. Different compounds will be chosen according to the approved indications and clinical practice. Therefore it is not possible to provide a specific trade and/or generic name.

female outpatient subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects aged =/\> 18 years and of reproductive age.
• Capacity to give consent for study participation, after being adequately informed of the aims, benefits, risks, time and motion of the study.

You may not qualify if:

• Participation in another clinical trial.
• Known or suspected (or history of) malignancy or chronic illness.
• Serious organic or mental disease diagnosed by a psychiatrist (e.g., major depression currently treated with antidepressant medication) suspected on the basis of the medical history and/or clinical examination.
• Conditions that may affect the compliance to the study.
• Contraindications to therapy with the study drug or hypersensitivity to the study drug (active ingredient or excipients of the formulation).

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Ambulatori di Medicina della Sessualità e Andrologia

Florence, Italy

Location

Related Publications (5)

• Battaglia C, Battaglia B, Mancini F, Nappi RE, Paradisi R, Venturoli S. Moderate alcohol intake, genital vascularization, and sexuality in young, healthy, eumenorrheic women. A pilot study. J Sex Med. 2011 Aug;8(8):2334-43. doi: 10.1111/j.1743-6109.2011.02310.x. Epub 2011 May 19.

  PMID: 21595833 BACKGROUND

• Battaglia C, Nappi RE, Mancini F, Cianciosi A, Persico N, Busacchi P, Facchinetti F, de Aloysio D. Menstrual cycle-related morphometric and vascular modifications of the clitoris. J Sex Med. 2008 Dec;5(12):2853-61. doi: 10.1111/j.1743-6109.2008.00972.x. Epub 2008 Aug 28.

  PMID: 18761595 BACKGROUND

• Bullivant SB, Sellergren SA, Stern K, Spencer NA, Jacob S, Mennella JA, McClintock MK. Women's sexual experience during the menstrual cycle: identification of the sexual phase by noninvasive measurement of luteinizing hormone. J Sex Res. 2004 Feb;41(1):82-93. doi: 10.1080/00224490409552216.

  PMID: 15216427 BACKGROUND

• Wierman ME, Nappi RE, Avis N, Davis SR, Labrie F, Rosner W, Shifren JL. Endocrine aspects of women's sexual function. J Sex Med. 2010 Jan;7(1 Pt 2):561-85. doi: 10.1111/j.1743-6109.2009.01629.x.

  PMID: 20092453 BACKGROUND

• Scavello I, Maseroli E, Di Stasi V, Cipriani S, Verde N, Magini A, Maggi M, Vignozzi L. Nomegestrol acetate/17beta-estradiol does not negatively alter the vascular resistance of clitoral arteries: a prospective, exploratory study. Int J Impot Res. 2020 Mar;32(2):239-247. doi: 10.1038/s41443-019-0162-7. Epub 2019 Jul 1.

  PMID: 31263248 RESULT

MeSH Terms

Conditions

Contraception Behavior; Sexual Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Mario Maggi

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor of Endocrinology

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 24, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

IT (1)