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Contraceptive UsagePhase 4COSEXNCT02613039

Oral Contraceptive Therapy and Sexuality

A Phase 4 study testing Combined Estrogen-Progestin Oral Contraceptives in people with Contraceptive Usage and Sexual Behavior, run by University of Florence at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Combined Estrogen-Progestin Oral Contraceptives
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteItaly
Study dates
Oct 2015to Feb 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ambulatori di Medicina della Sessualità e Andrologia

    Florence

Other trials in Italy

About this study

Official title: Study on the Effect of Combined Oral Contraceptive Therapy on Female Sexuality, Body Image and Mental Health

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.

Read the detailed description

Primary study objective Evaluation, in a sample of female outpatient subjects, of the effect of oral contraceptives (OCs) on sexual function and distress, evaluated with the FSFI (Female Sexual Function Index) and FSDS (Female Sexual Distress Scale Revised) questionnaires and through clitoris artery hemodynamic parameters.

Secondary study objectives

Evaluation, in a sample of female outpatient subjects, of the effect of OCs on:

  • body image perception, evaluated with the BUT (Body Uneasiness Test) questionnaire;
  • mood and mental status, evaluated with the MHQ (Middlesex Hospital questionnaire);
  • hormonal and metabolic parameters.

Exploratory Objectives: evaluation of the relationships between hormonal parameters, clinical scores and sexual function, body image, mood in the study population.

Being tested
Combined Estrogen-Progestin Oral Contraceptives
Keywords
oral contraceptives, female sexuality
Medical subject headings
Contraception Behavior, Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined Estrogen-Progestin Oral ContraceptivesDrug

    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.

Study groups in NCT02613039
Study groupRoleWhat they receive
female outpatient subjectsOtherPatients requiring combined Oral Contraceptives therapy.
Receives: Drug: Combined Estrogen-Progestin Oral Contraceptives

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months and 12 months

  2. 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.

    Measured: 6 months and 12 months

  3. 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.

    Measured: 6 months and 12 months

Secondary outcomes (16)

  1. Changes in body image perception

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

    Measured: 6 months and 12 months

  2. Changes in mood and mental status

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

    Measured: 6 months and 12 months

  3. Changes in glycaemia

    A significant difference in glycaemia levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  4. Changes in glycated hemoglobin (HbA1c) levels

    A significant difference in HbA1c levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  5. Changes in insulin levels

    A significant difference in insulin levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  6. Changes in total cholesterol levels

    A significant difference in total cholesterol levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  7. Changes in HDL (high-density lipoprotein) cholesterol levels

    A significant difference in HDL cholesterol levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  8. Changes in triglycerides levels

    A significant difference in triglycerides levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  9. Changes in total testosterone levels

    A significant difference in total testosterone levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  10. Changes in estradiol levels

    A significant difference in estradiol levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  11. Changes in SHBG (sex hormone binding globulin) levels

    A significant difference in SHBG levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  12. Changes in LH (luteinizing hormone) levels

    A significant difference in LH levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  13. Changes in FSH (follicle-stimulating hormone) levels

    A significant difference in FSH levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  14. Changes in prolactin levels

    A significant difference in prolactin levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  15. Changes in delta4-androstenedione levels

    A significant difference in delta4-androstenedione levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

  16. Changes in Dehydroepiandrosterone sulfate (DHEAS) levels

    A significant difference in DHEAS levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionFeb 2018
  4. Study completionFeb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02613039
Sponsor's protocol ID
ANDRO-AOUC-2015-2
Acronym
COSEX
Status last verified
Mar 2020
First submitted
18 Nov 2015
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21595833

  • 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.

    PubMed 18761595

  • 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.

    PubMed 15216427

  • 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.

    PubMed 20092453

  • 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.

    PubMed 31263248

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Combined Estrogen-Progestin Oral Contraceptives in people with Contraceptive Usage and Sexual Behavior, run by University of Florence at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in sexual function (FSFI score) (time frame: 6 months and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02613039, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.

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